Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislation

General – Principle support for the IVDR objectives: Safety and quality for healthcare are essential – criticism: The IVDR does not sufficiently take into account the specific challenges faced by SMEs – current rules hamper product innovation – request: More proportionality to the product risk class, greater harmonisation and practicality for SMEs 1.

Filed in German · English published by the European Commission

This submission calls for urgent measures to make EU medical device approvals and change notifications faster, more predictable, and less burdensome, ensuring timely patient access to innovation and preserving Europes competitiveness in medical technology.

Filed in Czech · English published by the European Commission

Thank you for the opportunity to provide feedback during this portion of the targeted revision initiative. The list below summarizes the changes that, in our opinion, present the best opportunities for strengthening, streamlining, and future-proofing the EU MDR.

We welcome many aspects of the IVDR. However there are significant issues arising. These include withdrawal of key reagents for small volume tests (such as crossmatching for transplantation purposes), and in accessing testing in specialist centres in third countries for rare diseases.

The opinion of GeneProof a.s. on the targeted amendment of the IVDR (Regulation (EU) 2017/746) The limited validity of certificates (max. 5 years) results in repeated administrative cycles without additional safety benefits. The lack of an NB preliminary opinion mechanism leads to frequent rejection and re-submission of dossiers.

Filed in Czech · English published by the European Commission

The University of Groningen (RUG) is an innovative research university that includes the University Medical Center Groningen (UMCG), a large teaching hospital and research center for medicine, patient care, education, and innovative research, particularly focused on Healthy Ageing.

The European Patients Forum (EPF) welcomes the opportunity to provide feedback on the targeted revision of the EU regulations for medical devices and in vitro diagnostic devices. The revision should focus on reducing unnecessary administrative burdens that do not contribute to patient safety, information, or transparency, while contributing to more equitable access to safe and effective devices for all patients.

BSI has more than 30 years experience as a full scope EU Notified Body, UK Approved Body, MDSAP Auditing Organisation, ISO 13485 Certification Body, Registered Certification Body for the PMDA and supports conformity assessment to authorities in more than 12 other countries.

Leica Microsystems welcomes the opportunity to provide feedback to the European Commission on the implementation of the EU Medical Devices Regulation (MDR). As a manufacturer of surgical microscopes, Leica has embarked on a digital transformation journey while applying the latest regulatory requirements under the MDR, in close collaboration and alignment with the respective Notified Body.

EFPIA welcomes the European Commissions call for evidence gathering input to address the identified problems highlighted in the MDR-IVDR targeted evaluation of March 2025 and is providing input related to drug-device/diagnostic used together (combined products) during clinical development and life cycle.

GBA Central Lab Services is an ISO/IEC 17025-accredited central laboratory operating under the local German law (RiliBÄK), Good Clinical Practice (GCP) and ICH-M10 for Bioanalytical method validation. WE provides analytical services for international clinical drug trials (phases IIV).

Filed in German · English published by the European Commission

The European Society for Medical Oncology (ESMO) - a professional society representing over 45,000 members from 179 countries and territories - commends the Commission for its efforts to resolve the existential threat to oncological research in the EU, posed by the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

EuromContact, representing manufacturers of contact lenses and lens care products, welcomes the targeted revision of the MDR and its objectives to streamline and future-proof the regulatory framework by reducing the administrative burden and enhancing predictability and cost-efficiency, while preserving a high level of public health and patient safety.

MEDAC is a German-based pharmaceutical company with cancer and autoimmune medicines, but also has a medical technology and diagnostics business. medac therefore welcomes the European Commission’s ambition to streamline and future-proof the regulatory framework by reducing administrative burdens and increasing predictability and cost-effectiveness.

Filed in German · English published by the European Commission

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents small to mid-sized innovative companies in pharmaceuticals, biotechnology, and medical technologies across Europe. EUCOPE welcomes the European Commissions initiative to revise the MDR and IVDR to ensure a more predictable, proportionate, and innovation-friendly framework.

As a MedTech SME and former EU-based startup, I appreciate the opportunity to contribute to the European Commissions consultation on the targeted revision of the Medical Device Regulation (MDR). This feedback reflects our lived experience navigating MDR from two vantage points: first as a small enterprise committed to compliance, and later as a startup forced to pivot away from the EU market.

JANE-2, uniting 121 institutions from 29 countries, is a unique initiative under the Europes Beating Cancer Plan to establish seven new European Networks of Expertise (NoE). The ambition of the NoE on Omics technologies is to integrate innovative omics approaches into standard cancer care in a sound, sustainable, and equitable way for all EU citizens.

--Please find our response to the call for evidence attached-- SUMMARY: The BioMed Alliance supports the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to safeguard patient safety and ensure innovation. However, implementation has revealed significant challenges that must be addressed to protect patients access to safe, effective, and innovative technologies.

Statement on the further development of the MDR/IVDR Summary 1.Please bring the Request for Evidence on Well-Established technologies" (WETs). This measure would protect long-established existing products on the market from being withdrawn by manufacturers (due to excessive costs). 2.Corrections to the wording and clearer guidelines for the classification of products.

Solventum welcomes the opportunity to submit this input, in response to the European Commissions public consultation on the targeted revision of EU rules for medical devices and in vitro diagnostics. Implementation complexity of the Medical Devices Regulation (MDR), inconsistent interpretations by Notified Bodies (NBs) and lengthy approval timelines are delaying patient access to critical technologies.

As a small orthopedic implant company that has served EU patients safely for 15 years, we support the goal of ensuring patient safety. However, the current Medical Device Regulation (MDR, 2017/745) creates unintended harm that must be addressed. 1.

Firstly, I would like to thank the EU Commission and associated parties such as MDCG for the initiation of this call for evidence. Other areas that have benefited the industry include the amendment of the application of eIFU for certain devices - a great move forward. This could be further expanded - however, I note the potential ethical issues with the older generation or less technically literate.

The European Renal Association (ERA) strongly welcomes the revision of the EU Medical Devices (MD) Regulation (MDR, 2017/745). The EUs transition from the MD Directive to the MDR, aimed to enhance patient safety through stricter oversight across the lifecycle of medical devices.

Global Heart Hub, the international alliance of cardiovascular patient organisations, supports the Commission's initiative to revise the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to reduce administrative burdens and enhance efficiency. However, we emphasize that simplification must not come at the expense of patient protection.

GIRP, the European Healthcare Distribution Association, welcomes the opportunity to contribute to the European Commissions Call for Evidence on the targeted revision of the EU rules for medical devices and in vitro diagnostics.

One of the main difficulties encountered by manufacturers is the heterogeneity of interpretation between the different notified bodies. For the same regulatory requirement, some require a much higher level of documentation than others, or may change their expectations throughout the certification process. This variability creates unpredictability that weighs heavily on project planning and associated costs.

From a technical regulatory perspective for a global manufacturer and supplier of medical devices in the area of airway management, anaesthesia, critical care and oxygen, aerosol therapy, the targeted evaluation by the European Commission of the Medical Device Regulation (MDR) to support patient access, innovation, regulatory efficiency and objectives to improve device availability and streamline regulatory…

TMF, MFT, VUD, BDA, BDP, DGAI, DGINA, DGP, DGMKG, DGTelemed, GMDS, DIVI, CTC-A, Aktin, BIH QUEST and BOHAIME jointly welcome the EU’s objective to ensure patient safety, but to promote innovation by reducing the red tape of the MDR/IVDR provisions.

Filed in German · English published by the European Commission

Cancer Patients Europe (CPE) response to the European Commissions Call for Evidence on the targeted revision of EU rules for medical devices and in vitro diagnostics (MDR/IVDR) Cancer Patients Europe (CPE) welcomes the opportunity to contribute to the targeted revision of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

This feedback on the EU MDR 2017/745 underscores the need for a more proportionate, risk-based regulatory framework that maintains patient safety while reducing administrative burden. Key recommendations include removing re-certification, streamlining reporting obligations, harmonizing Notified Body practices, promoting digitalisation, enhancing international cooperation, and aligning the EU MDR with adjacent…

As both a medicinal product and medical device manufacturer, Takeda Pharmaceuticals welcomes the opportunity to provide evidence on specific challenges the MDR and IVDR have presented to pharmaceutical companies within the EU. Please find attached detailed information on the key challenges Takeda has encountered due to MDR and IVDR along with some proposed solutions to address these issues in the future.

The Federal Chamber of Doctors would like to thank you for the opportunity to comment. The Federal Medical Chamber supports the objective of the revision of the Medical Devices and In vitro Diagnostics Ordinances to address supply shortages and withdrawals from the market of key medical devices by simplifying rules related to conformity assessments without jeopardising the safety of patients.

Filed in German · English published by the European Commission

SM Europe – ORLIMAN France Distributor of DM Class 1 Orliman SM Europe thanks the European Commission for its consultation on the MDR. Concerning the affixing of the direct UDI-DI to the device, certain compression products, ortheses or moulded or injected apparatus have a manufacturing process that does not allow easy direct affixing in accordance with Section 4.10 of Part C of Annex VI to the MDR.

Filed in French · English published by the European Commission

As rare disease drug developers operating within the GxP environment, we face significant challenges under the IVDR, due to the withdrawal of numerous diagnostic tests from the market. The stringent requirements for clinical evidence and performance data are particularly difficult to meet in the context of rare diseases, where patient populations are small and geographically dispersed, offering minimal commercial…

Irish Medtech (IM), Irelands trade association for medtech, welcomes the opportunity to respond. Ireland is a global medtech hub, with over 450 companies (80% SMEs), 9 of top 10 medtech companies, 2nd largest exporter in the EU, and the largest employer of medtech professionals (per capita) in the EU.

As a responsible for referent laboratory for molecular diagnosis in acute leukemias within a university hospital, I wish to provide feedback on the application of the European IVDR to in-house diagnostic devices (IH-IVDs). In-house tests are essential for patient care, particularly in the diagnosis and management of rare or complex diseases like acute leukemias.

IVDR has introduced challenges for clinical trial Sponsors who use Central Laboratories for the testing of patient samples. Although the majority of tests performing at Central Labs in the EU are commercially available and CE marked, Sponsors also rely on Central Labs to develop esoteric tests to enable critically important data to be generated to support the trial.

We appreciate the opportunity to submit feedback regarding the ongoing revision of the MDR/IVDR. As stakeholders with active involvement in the European regulatory framework, we acknowledge the Commissions commitment to patient safety and fostering an environment that drives innovation.

The European Social Insurance Platform (ESIP), representing social and health insurers in the EU including those responsible for the assessment and/or reimbursement of medical devices, notes the European Commissions initiative to present a targeted revision of Regulations (EU) 2017/745 (Medical Devices Regulation, MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation, IVDR).

MedTech Europe welcomes legislative reform, provided it delivers a regulatory system that enhances competitiveness, is efficient, lean and fit for purpose, supports innovation, is well-governed and ensures patients access to devices. Short-term relief measures are needed in parallel to the reform (e.g.

Joint statement by the professional association Deutscher Pathologinnen und Pathologen e.V. (BDP) Deutsche Gesellschaft für Pathologie eV (DGP) Berufsverband Deutscher Humangenetiker e.V. (BVDH) Deutsche Gesellschaft für Humangenetik e.V. (GFH) Professional Association of German Laboratories e.V. (BDL) Accredited Laboratories in Medicine e.V.

Filed in German · English published by the European Commission

The British Dental Industry Association welcomes efforts to address the systemic challenges facing the regulation of medical devices under the EU MDR. We believe that a targeted legislative intervention, coupled with appropriate ongoing support and oversight, can support patient outcomes through improved access to dental devices whilst creating a more supportive environment for manufacturers and other economic…

SPECTARIS welcomes the European Commission’s initiative on the targeted revision of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The medical engineering industry in Germany stands for innovation, quality and security of supply. However, the current regulatory environment is increasingly jeopardising the availability of medical devices and in vitro diagnostic medical devices in Europe.

Filed in German · English published by the European Commission

EUROM welcomes the opportunity to provide feedback on the targeted revision of the EU rules for medical devices (MDR) and in vitro diagnostics (IVDR). This revision should aim to reduce bureaucratic burdens, strengthen governance and accountability, lower costs, foster competition and innovation, support small and medium-sized enterprises (SMEs), ensure consistency with horizontal legislation, and address future…

While the foundations of the MDR Regulation are solid, the practical implementation has led to unbalanced burden and cost pressures, a lack of predictability, a brake on innovation and risks to the availability of existing resources. The administrative and financial burden is disproportionately high in relation to the risk and nature of the products, especially for devices that have been in safe use for decades.

Filed in Dutch · English published by the European Commission

Zimmer Biomet, a global leader in medical technology, has always supported the good intentions of all parties to implement the EU Regulation 2017/745 on medical devices (MDR) as smoothly as possible within the defined transition period. However, despite extensive efforts, the system is not functioning in its intended robust, transparent, predictable and sustainable way that maintains safety and supports innovation.

The Association of Manufacturers and Suppliers of Medical Devices (AVDZP), representing the Czech MedTech industry across the full value chain, welcomes the opportunity to contribute to the targeted revision of Regulation (EU) 2017/745 (MDR).

FENIN (Federación Española de Empresas de Tecnología Sanitaria) is the business organisation that represents companies providing health technology in Spain throughout our National Health System. FENIN comprises more than 300 companies, ranging from start-ups, small and medium-sized enterprises to multinationals, which manufacture, import or distribute both hospital and pharmacy products, including, inter alia, in…

Filed in Spanish · English published by the European Commission

Clarify definition of Intended purpose and intended use. For the readability of the regulation only use either Intended purpose or intended use, or at least include the statement from MDCG 2020-6 that they have the same meeting. Clinical Data Too high requirements to justify equivalence.

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of the Regulation (EU) 2017/745 on Medical Devices (MDR) and the Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices (IVDR).

We consider that the introduction of the MDR has clarified for both manufacturers, distributors and final customers the responsibility of each party to ensure that each medical device complies with the requirements. Also the responsibility of the distributor to ensure that the entire CE marking structure assists throughout the lifetime of the device.

Filed in Swedish · English published by the European Commission

It is unclear when the manufacturer has the role and how to deal with this change during the journey. (OVAC, OSA, OSB). Traceable MDR: traceable which materials are used at what time (possibly from which batch) and their traceability. Record, if any, any modifications made to the device. Use of software within the chain and its possible MDR obligation. Examples: an OSB shoe that is internally adapted.

Filed in Dutch · English published by the European Commission

Diagnostics as a key to bespoke health When you are ill, you want only one thing: improve. Prefer to stay healthy. The right treatment at the right time for the right patient is getting closer, thanks to advances in diagnostics and treatments. Only these innovations need to achieve this in practice. At a time when the technology is ready to deliver bespoke health, it is stuck in a forest of rules and procedures.

Filed in Dutch · English published by the European Commission

AESGP Feedback to the European Commissions Call for Evidence on Targeted revision of the EU rules for medical devices and in vitro diagnostics. AESGP, the Association of the European Self-Care Industry, represents the manufacturers of non-prescription medicines, food supplements, and self-care medical devices in Europe, an area also referred to as self-care or consumer healthcare products.

The IHI project HEU-EFS aims to establish a harmonised approach to Early Feasibility Studies (EFS) for medical devices in the European Union. ISO 14155:2020 defines EFS as limited clinical investigations which aim to evaluate the initial clinical safety and performance of a device.

We feel that, in its current design, MDR complicates the Swedish model for the supply of auxiliary products, where the reuse of medical devices is a key element. Through reuse, we can provide personalised tools to a large number of users in an economically and environmentally sustainable way, in line with the EU’s circular economy objectives, without compromising product safety.

Filed in Swedish · English published by the European Commission

As SME manufacturer of in vitro diagnostic devices, the impact is significant, complex and burdensome in terms of economic investment, administrative costs, human resources and infrastructure, both now and in the future. Achieving IVDR certification has meant sacrificing and/or postponing innovation projects, and therefore reducing our competitive market presence.

- Define substantial change for devices in different risk classes. - Set directions for review timelines for Notified Bodies. Currently, some Notified Bodies request a wide range of changes to be reviewed in advance, but with highly unpredictable review times. This causes problems for the manufacturers product release planning. - In general, better alignment between Notified Bodies should be targeted.

Dräger supports the European Commissions objective to modernize the regulatory framework for medical devices. We particularly welcome initiatives that reduce administrative burden, increase cost efficiency and predictability, while ensuring that the high standards of patient safety and public health are maintained.

The Swedish Society for Clinical Microbiology organizes medical specialists and biologists working within diagnostic microbiology in Sweden. The society has been active in supporting the Swedish clinical microbiology laboratories in implementation of IVDR, in particular compliance with article 5.5 for in-house IVDs.

The Chamber of Commerce and Industry for Munich and Upper Bavaria represents the interests of around 1000 mainly medium-sized enterprises with 80.000 employees in the Bavarian medical technology sector. We welcome the European Commission’s ambition to evaluate and specifically revise the regulatory framework for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Filed in German · English published by the European Commission

BEAM Alliance represents 70+ European SMEs developing 120+ innovative products against antimicrobial resistance (AMR). AMR already causes 35,000 deaths in Europe and economic impacts that amount to billions, and these figures will continue to grow.

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of over 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe.

Zorg Inkoop Netwerk Nederland welcomes the European Commissions initiative to launch an early evaluation of the EU Medical Device Regulation (MDR). As the National Reporting Point for Shortages of Medical Devices in the Netherlands, we provide timely insights into supply disruptions and actively share knowledge on available alternatives.

The Chamber of Commerce and Industry for Munich and Upper Bavaria represents the interests of around 1000 mainly medium-sized enterprises with 80.000 employees in the Bavarian medical technology sector. We welcome the European Commission’s ambition to evaluate and specifically revise the regulatory framework for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Filed in German · English published by the European Commission

Thank you for allowing stakeholders of different colors to comment on the MDR Revision. Here are the first recommendations with rest in PDF. (1) Increase the harmonization by recognizing and referring to existing internationally recognized institutions: - IMDRF i.e. align with guidance on Technical File (e.g.

We, the Federal Association of Self-help Austria (BVSHOE), is the umbrella association of Austria’s federal, thematic self-help and patient organisations, see both important opportunities and obstacles in the reform of medical devices. The focus of this reform should be on the well-being of patients and, above all, on facilitating the use of medical devices.

Filed in German · English published by the European Commission

The Austrian Social Insurance considers the targeted revision of EU rules on medical devices (MDR) and in vitro diagnostics (IVDR) an important step towards improving patient safety and the quality of treatments using medical devices as well as in vitro diagnostics (IVD).

Thank you for the opportunity to comment on the targeted revision of the EU rules for medical devices. Philips shares the concerns as raised in the call for evidence. We believe a reform of the regulatory framework is necessary to ensure availability of medical devices for patients and to strenghten EU competitiveness. The announced revision is an important pilar of the EU Life Science Strategy.

While good in intention, all the stuff related to and around the medical technology and product directive are a major and very hard stop for small inventors and minor companies. The effort to be able to start a development at all, not even finish with a viable product, just starting, are now quite prohibitive. This are already affecting innovation and driving away delevopment.

Members of EAAR act as independent Authorised Representatives on behalf of thousands of non-EU manufacturers. EAAR offers its contribution on the following aspects: 1) Improvement of AR involvement in EUDAMED Device Registration, 2) Clarity on the verification requirement for ARs, 3) Clarity on AR involvement in vigilance matters, 4) Rewording of liability for ARs.

APPLiA represents hosehold appliances manufacturers in Europe. More info about us can be found at www.applia-europe.eu. We would like to respond to the Medical devices and in vitro diagnostics targeted revision of EU rules call for evidence with follwoing comments/questions.

Edwards Lifesciences, a global leader in breakthrough structural heart innovations investing 19% of annual revenues in breakthrough research & innovation, strongly welcomes the upcoming reform of the EU Medical Device Regulation process.

The Medical Laboratories of Switzerland (FAMH) fully support the recommendations outlined in the article Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics by Cobbaert et al. (on behalf of EFLM C-ERA; supported by the DGKL board).

More efficient approaches to the certification cycle of medical devices The limited validity period of certificates to five years should be abolished. Instead, it calls for a more efficient and risk-based certification cycle based on post-market data.

Filed in German · English published by the European Commission

- In clinical pathology, we have a wide spectrum of histological, cytological and immunohistochemical stains as well as control material for internal use that are considered as in-house IVDs or self-validated RUO -methods according to IVDR. Only a small minority of the methods in histology/sytology are simple IVD-labeled tests that are used as such and only according to their instructions for use.

The Genomics Laboratory has dozens of in-house tests for diagnostic use. The reason for using in-house tests is that there are no IVD tests for these rare diseases and there is a permanent clinical need for these tests.

Filed in Finnish · English published by the European Commission

That contribution concerns the absence of a clear definition in Regulation 2017/745 of a reusable medical device and the application of the requirements linked to that status, in particular the direct marking of the UDI.

Filed in French · English published by the European Commission

Veinsound welcomes the Commission's initiative to conduct a targeted revision of the Medical Device Regulation (MDR). We are a European SME focused on developing cutting-edge, non-invasive vascular treatment solutions designed to address chronic venous insufficiencya widespread condition currently managed largely through complex, invasive procedures.

Submission on behalf of the Regulatory Affairs Professionals Society (RAPS) Belgium Local Networking Group We welcome the European Commissions Call for Evidence and fully support the targeted revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Input received from several laboratories highlights a number of practical difficulties encountered since the implementation of the IVDR regulation. These examples illustrate challenges that may affect the continuity and flexibility of diagnostic activities in specialised or reference settings.

— Harmonisation of rules for notified bodies (tariffs, maximum devaluation deadlines for certification and notification of changes, proportionate definition of changes to be notified, early dialogues to clarify expectations from the start of the process).

Filed in French · English published by the European Commission

Comment on the Implementation of the IVDR (Article 5(5)) Public Health Authority. Head of National Refrence Centre and a Member of Avisory Board of Chief Hygienist. The implementation of Regulation on in vitro diagnostic medical devices (IVDR) has created significant challenges for both manufacturers and clinical microbiology laboratories and publich health laboratories as well.

Opinion on the targeted revision of EU rules on medical devices and in vitro diagnostic medical devices (MDR/IVDR): Digitalisation and data-driven processes as key to efficient, safe and innovation-friendly regulation The requirements of the EU-MDR and IVDR ensure high patient safety, but lead to significant administrative burdens in practice that hamper innovation and market access.

Filed in German · English published by the European Commission

The European Society of Radiology (ESR) welcomes the opportunity to submit a call for evidence on the evaluation of the Medical Devices Regulation. The evidence that follows is based on the experience prevalent in interventional radiologist units, which have been more affected by the shortcomings of the MDR.

Opinion to the European Commission on the effects of IVDR regulation on Tyks Laboratorios for in-house clinical chemistry studies. The new legislation will bring additional work to clinical laboratory diagnostic practitioners in the form of in-house diagnostic documentation, documentation maintenance and monitoring of devices.

Filed in Finnish · English published by the European Commission

As a virtual manufacturer, we welcome the Commission's targeted revision of the EU rules for medical devices. Ensuring patient safety should be the responsibility of both device manufacturers and clinicians using the devices.

To ensure that Europe remains a fertile ground for innovation while maintaining the highest standards of safety and clinical value, we believe that several adjustments to the current regulatory framework are necessary. A first priority is the establishment of a structured pre-submission dialogue.

TÜV SÜD Summary: Public perception often misrepresents notified bodies as bottlenecks in the MDR/IVDR certification process. In reality, TÜV SÜD and other notified bodies have built sufficient capacity and have reached a steady operational state. We see that delays are increasingly caused by late or incomplete manufacturer submissions or responses.

Metrology, the science of measurement, plays a crucial role in developing and improving methods of quality assurance and standardization. It provides a means to achieve comparability of measurement results across different analytical systems, between laboratories, and across patient populations. Regulation of laboratory tests is important to ensure safety and effectiveness for the populations served.

ABHI welcomes the European Commissions targeted evaluation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Representing UK HealthTech manufacturers, developers and service providers across the UK, EU and global markets, ABHIs submission reflects collective member experience and highlights areas for targeted revision to support patient access, innovation and regulatory…

Both in academia in professional practice and, it is experienced that the current regulatory framework significantly restricts the availability of assistive devices and the ability to make small-scale, client-specific adaptations. This has direct consequences for client participation as well as for the quality of education provided to future healthcare professionals.

We run and represent a laboratory diagnosing neuromuscular diseases (investigating muscle biopsies). The laboratory was established 50 years ago and has exclusively been working with muscle diagnostics. Most neuromuscular diseases are rare.

HealthTech Finland thanks the Commission for opening the Call for Evidence for the medical device regulations (MDR and IVDR). The performance and safety of medical devices (MD) and in vitro diagnostics medical devices (IVD) is crucial to European patients. However, also the availability of devices to patients is a critical part of high-quality care and patient safety.

The Chamber of Dental Technicians welcomes the European Commission’s initiative aimed at simplifying and streamlining the regulatory framework for medical devices while maintaining a high level of protection of public health and patient safety. We see the problem in the disproportionate burden that small laboratories represent:

Filed in Czech · English published by the European Commission

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices (IVDR).

Sufficient views were shared on the excessive burden of complying with the IVDR. Here are a few opportunities for improvement: 1. Clear communication about what is allowed, even though it is not specifically formulated in the IVDR. This includes: (a) the non-necessary fulfilment of certain requirements (e.g.

Filed in German · English published by the European Commission

We strongly support a targeted revision of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) to safeguard patient access while maintaining a high level of health protection. Based on experience across Class IIIb portfolios (legacy and new), interactions with Notified Bodies (NB), and preparation for EU- and non EU audits, we recommend pragmatic, high impact changes that simplify without lowering the bar for safety…

The administrative burden is disproportionate for the self-manufacture that needs to be present in Article 5(5) laboratories and which our organisation considers necessary for diagnostic analyses also in the future. For around 450 products, it is estimated that this has generated one year of additional work in working hours, including ongoing evaluations.

Filed in Swedish · English published by the European Commission

Opinion to the European Commission on the effects of IVDR Regulaation on the in-house studies of the Laboratory for Clinical Microbiology of tyx. The Clinical Microbiology Laboratory of the Central University Hospital of Turku appreciates the opportunity to comment on the reform of the Commission’s IVDR and the possibility to raise expertise on laboratory diagnostics in Article 5.5.

Filed in Finnish · English published by the European Commission

Submission to the European Commissions Targeted Revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Submitted by: European Congenital Heart Disease Organisation (ECHDO) ECHDO represents congenital heart disease (CHD) patient associations across Europe, advocating for children and adults born with heart defects, the most common birth anomalies, who depend on high-risk, often…

Confindustria Dispositivi Medici is the Italian trade association for the medical device and in-vitro diagnostic industries. It represents from SMEs to multinationals and plays a key role in innovation and advocacy. The Italian medical devices sector generates almost 19 billion, with 4648 firms and 130520 employees.

The Medtech & Pharma Platform Association (MPP) wishes to respectfully draw attention to a series of persistent challenges that continue to hinder the effective and proportionate functioning of the European Unions regulatory framework governing medical devices and in vitro diagnostics.

Dear Sir, for the National Chamber of Commerce of Medical Devices POLMED (hereinafter: POLMED Chamber) thank you very much for this initiative. We would like to point out that we act as an official trade organisation representing manufacturers, importers and distributors of medical devices. In their day-to-day work, we are a substantive partner in dialogue to change and improve the functioning of the health system.

Filed in Polish · English published by the European Commission

In working on class 1 products, we face the following challenges based on the regulatory framework. Service life: In the MDR, it is unclear what the term ‘lifetime’ refers to (technical, economic, actual). Different descriptions of lifespan by manufacturers, unclear about preventive maintenance, risk assessments can extend the lifespan.

Filed in Swedish · English published by the European Commission

The Association of Diagnostica Industrie e.V. (VDGH) welcomes the European Commission’s plan to fundamentally modernise the regulatory framework for in vitro diagnostic medical devices and to strike a better balance between regulatory safety and economic feasibility.

Filed in German · English published by the European Commission

As a French SME operating in the medical device sector, we welcome the European Commissions initiative to simplify and streamline the EU regulatory framework for medical devices. We urgently call for measures to reduce administrative burden, enhance predictability, and foster innovation and competitiveness, while maintaining the highest standards of patient safety.

Novo Nordisk appreciates the opportunity to provide feedback to the call for evidence on the targeted revision of the EU rules for medical devices and in vitro diagnostics. We support the initiative to streamline and future-proof the regulatory framework while preserving a high level of public health and patient safety.

The MDR and IVDR originally aimed at ensuring higher patient safety and more uniform regulation across the EU. This was and is an important goal. Unfortunately, we now have a regulatory system which has not only been difficult to implement, but which is also incredibly fragmented and burdensome. Many companies struggle with a slow and unpredictable certification process.

As an innovative manufacturer of medical devices, we believe that while the Medical Device Regulation (MDR) is generally strong, it requires significant improvements for medical device software and "digital health".

Feedback on the European Commissions Call for Input on Medical Device Regulation The European Commissions initiative to revise the Medical Device Regulation (MDR) is welcome. Ensuring patient safety and high-quality standards is highly important, at the same time the current framework is unintentionally slowing innovation, reducing patient access to modern neurosurgical technologies, and weakening Europes position…

As an SME with standard products, the MDR imposes enormous requirements, some of which are perceived as very disproportionate. Clear requirements for clinical evaluation and post-market surveillance of standard products, especially those for which there is little clinical data and for which a study would be disproportionate (needles, hypodermic needles, scissors, etc.).

Filed in German · English published by the European Commission

Pharma Deutschland e.V. welcomes the European Commissions initiative to simplify EU rules for medical devices and to strengthen the competitiveness of the European medical device sector both within the internal market and globally. We particularly support the objective to foster innovation and reduce dependencies.

The Finnish Diabetes Association is pleased to submit our response to the Call for Evidence on the targeted revision of the EU rules on Medical Devices and in vitro diagnostics. Finnish Diabetes Association finds it very important to ensure the safety of medical devices available on the European market.

1: Timeline and planning (resources and economy) impossible to plan internally. Notified body must commit to a general timeline and cost for approval (risk class level or EMDN-level). Postponement of timeline only due to manufacturer writing/creating additional evidence.

Labcorp is a global leader in innovative laboratory services and the market leader in central laboratory (CL) testing services. We have a strong R&D footprint in Europe, and our CL in Switzerland analyses samples from clinical trial patients in EMEA. A CL is a laboratory where specimen samples from clinical trial patients are analysed to guide decisions on clinical trials and patient management.

The Syndicat National de l’Industrie des Technologies Medical (Snitem) brings together in France the players in the medical technology and devices industry, including companies involved in digital health. It brings together 630 French or international companies, most of which are SMEs or DETI.

Filed in French · English published by the European Commission

The Medical Devices Regulation was to some limited extent a good idea (for example for the traceability or to know exactly the real legal manufacturer), but since its introduction, we have spent our time (re)writing documents, performing biocompatibility tests, evaluating new risks for MD on the market since decades, with no improvements at all on the products themselves.

F. Hoffmann-La Roche Ltd welcomes the opportunity to give input on the IVDR/MDR targeted revision. In-vitro diagnostics and medical devices are not only critical products in themselves to diagnose and treat medical conditions. They are also enablers for clinical research and to guide and administer pharmaceutical treatments. Our companys extensive portfolio comprises medical devices, IVDs and pharmaceuticals.

MedicalMountains GmbH welcomes the European Commissions initiative to launch an early evaluation and possible revision of the MDR. The system continues to show critical deficiencies, making this step both urgent and necessary. Immediate short-term solutions via delegated and implementing acts are essential; in addition, legislative measures must follow to secure sustainable long-term improvements.

Medical devices are essential for the delivery of high-quality healthcare to patients. Depending on the country, their procurement and management in the European hospital setting is often carried out under the authority of hospital pharmacists.

For our association - based on feedback from our 800 members - the following three points need immediate attention to bring back some of the competitiveness that has been lost due to MDR/IVDR: 1. Increase efficiency and predictability of Notified Bodies 2. Eliminate unnecessary administrative burden for manufacturers 3.

Full feedback provided in the attached document. In their current form, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices lack sufficient clarity around pre-clinical testing requirements, in particular, tests needed for conformity with the general safety and performance requirements and marketing authorisation of medical devices which may involve the use…

NBCG-Med Summary for EU COM Survey Submission NBCG-Med fully supports the objectives of the EU MDR and IVDR regulations to establish a robust, transparent, and sustainable framework that ensures high safety standards while fostering innovation.

Recommendations 1. Digitalisation of packaging information: replace paper manuals with digital instructions. 2. Standardisation of packaging: limit plastics, use single and recyclable materials. 3. Eco-design anchor: include the R ladder and ecodesign in MDR requirements and encourage the use of sustainable materials. 4.

Filed in Dutch · English published by the European Commission

Ladies and gentlemen, I would like to argue that the new requirements under Implementing Regulation (EU) 2025/1234 with regard to eIFU, which currently apply only to the MDR, should be extended to the IVDR. The POCT/patient near-patient use of class A devices by exclusively professionally trained staff is not explicitly considered and should be: The need for a printed IFU is assessed in a similar way as in…

Filed in German · English published by the European Commission

Ladies and gentlemen, I would like to argue that the new requirements under Implementing Regulation (EU) 2021/2226 regarding eIFU, which currently apply only to the MDR, should be extended to the IVDR. The POCT/patient near-patient use of class A devices by exclusively professionally trained staff is not explicitly considered and should be: The need for a printed IFU is assessed in a similar way as in…

Filed in German · English published by the European Commission

Critical areas requiring urgent action in the upcoming targeted revision of the MDR include: 0. Harmonization of definitions across MDR and accompanying legal documents. 1. Proportionate Recertification and QMS Audits Manufacturers call for a shift from full re-assessments to change-based reviews during recertification.

BPI welcomes the initiative. Targeted amendments are vital to foster innovation, patient safety and sustainable competitiveness within healthcare. BPI therefore advocates for the following: Reduce administrative burdens The current re-certification and post-market surveillance requirements under MDR and IVDR impose disproportionate, duplicative burdensparticularly on SMEs and mid-caps.

Mölnlycke is eager to share insights based on its MDR early-adopter experience to inform the forthcoming revision of the Regulation. While the current Medical Device Regulation (EU) 2017/745 is a significant step towards creating uniform legislation for all actors in the medical device sector, there are areas where the European Commission can improve clarity and oversight to ensure the availability of…

Devices for transcranial electrical stimulation (tES) that are specifically intended for research purposes onlythat is, without any medical purposeare widely used in basic research on cognitive processes, motor function, and sensorimotor integration. Under the Medical Devices Directive (MDD), such devices did not fall within the definition of a medical device, and were therefore outside the scope of the MDD.

We are a company that produces and markets medical devices. In our opinion, the MDR imposes excessive bureaucratic burdens and a waste of resources. The assessment procedures are overregulated. We believe it does not add safety and quality compared to the MDD 93/42.

We have been an IVD manufacturer since 1989. Tests that have been established on the market for over 30 years now require a complex re-approval process. The regulatory requirements that were applicable at the time are no longer considered sufficient, which results in a multitude of new testing obligations, new performance evaluations, and an extensive amount of regulatory documentation to be prepared.

We are a small family business with 10 employees and we have been exporting medical devices worldwide under their own name for more than 30 years. This business model OEM/PLM was tipped with the introduction of the MDR.

Filed in German · English published by the European Commission

Statement on the Impact of MDR and IVDR Regulations on Healthcare Organizations and Patient Safety As a healthcare organization, we wish to express our concern that the current MDR and IVDR regulations present significant challenges to the development and implementation of innovative medical solutions.

The Need for a Targeted Revision of the Medical Device Regulation (MDR) IGEPHA, the Austrian Self Care Association, represents manufacturers and distributors of consumer health products, including medical devices, non-prescription medicines and dietary supplements. We support a regulatory framework that ensures patient safety while at the same time promoting innovation and safeguarding availability.

Thank you for the opportunity to give feedback. One of the main root causes of the problems lies in the definition of a medical device in Article 2. The definition is very unclear and it is not unambiguous, which leads to extra work. As a result, nearly all objects and equipment used in healthcare may be interpreted as medical devices, which leads to overregulation.

Since 2014, the German medical devices industry has lost more than 10,000 micro and small enterprises, according to the findings of a recent study entitled The Medical Technology and Medical Devices Industry in Germany in Light of the Medical Device Regulation a special study commissioned by the Federal Ministry for Economic Affairs and Energy (BMWE).

We welcome the European Commissions initiative for the targeted revision of EU rules for medical devices and in vitro diagnostics, aiming to establish a future-proof regulatory framework, and appreciate the opportunity to provide feedback.

Below are our comments on the targeted reform of the IVDR. Reducing the administrative burden, including reporting obligations. Change Notification The burden on manufacturers from the January 10, 2025 obligations under Article 10a, requiring mandatory notification to Competent Authorities of foreseeable supply interruptions or discontinuations of that could lead to serious harm or risk to patient health at least…

As a Canadian manufacturer of IVD devices for over 50 years and exporter to Europe for many decades, focusing on safety and innovation, strongly welcomes the EU Commission's initiative to review the current IVDR, as the regulation in its current form poses significant, system-wide challenges, particularly for Small and Medium-sized Enterprises (SMEs).

We are a manufacturer of in vitro diagnostic (IVD) devices employing approximately 40 staff members. For more than 20 years, we have been developing and CE-marking a broad range of IVDs. This long-standing experience gives us deep expertise in ensuring the performance, safety and reliability of our products.

The European Society of Cataract and Refractive Surgeons (ESCRS), representing over 7,500 ophthalmic surgeons across Europe, welcomes the opportunity to contribute to the consultation on the targeted revision of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Swiss Precision Diagnostics welcomes the European Commissions initiative to simplify and streamline the EU regulatory framework for medical devices and in vitro diagnostics (IVDs). As a global manufacturer of pregnancy tests and fertility diagnostics, we strongly support measures that reduce administrative burden, improve predictability, and maintain patient safety whilst fostering innovation and competitiveness. 1.

The IVDR rightly aims to ensure that only safe and effective diagnostics reach the European market. Yet, its application has produced a system that is slow, bureaucratic, expensive, and does not reliably deliver the safety gains it promised. Strong regulation is vital, but the current path is not the most effective way to achieve patient safety and robust public health.

Subject: Feedback on the EU MDR/IVDR: problems for small businesses and system-wide delays To the European Commission, As a former notified body (NB) auditor, reviewer, and manager and current SME employee and consultant. I am writing to add my feedback on key problems with the MDR/IVDR rules.

Smith+Nephew welcomes the opportunity to provide feedback in support of the Commissions aims to make the medical device sector more competitive and make safety requirements more cost-efficient and proportionate.

The principles of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) are welcome, however implementation has fallen short in achieving its aims of a robust, transparent, predictable and sustainable regulatory framework for devices that ensures high levels of safety and supports innovation.

The Society of Toxicological and Forensic Chemistry (GTFCh) indicates that IVDR in current wording will substantially impede patient care and increase risks for lethal poisoning. The laboratories forming the working group Clinical Toxicology of the GTFCh offer around the clock advice and analysis in cases of suspected poisoning, thereby enabling rapid and targeted medical treatment of patients.

I would like to emphasize software. The MDCG 2019-11 guideline is not aligned with the MDR and is practically identical to the equivalent document for 93/42/EEC. It is necessary to be more aligned with the spirit of the law and not introduce concepts that differ from those of the law: in the event of a dispute, it is the law that counts, so it is necessary to be rigorous.

Dear Members of the European Commission, On behalf of Emagine AG, a Switzerland-based medical innovation company in the field of ophthalmology, I am writing to raise our concern regarding the current regulatory hurdles we are facing in the CE marking process for our novel penetration enhancer eye drops.

Proposed Regulatory Considerations: Labelling Requirements for Class I Medical Devices: Consider allowing Class I medical devices to bear only essential information on the product labellingsuch as the lot number and reference numberwhile permitting the omission of elements like the Data Matrix code, where appropriate and justified.

Overall: AdvaMed believes that the current issues in MDR/IVDR implementation are best addressed through application of both short-term measures, to be implemented as soon as possible, ideally this year, in combination with longer-term measures, as outlined in these two papers: medtech-europe_mdr_ivdr_leaflet_four-urgent-targeted-measures-1.pdf; joint-discussion-paper-on-future-governance-of-medical-technologies.pdf.

Ladies and gentlemen of the European Commission, in the context of your current consultation on the targeted revision of the MDR and IVDR, we, as a medium-sized medical technology company, would like to share our practical experience and concerns.

Filed in German · English published by the European Commission

We welcome the opportunity to provide feedback on the revision of the MDR rules. As a manufacturer certified under the MDD in classes I, IIa, and IIb (implantable), with over a decade of experience placing safe devices on the market, we strongly align with the concerns raised by industry peers and wish to share our perspective as an SME.

As a European medical device manufacturer (SME) with four other affiliates, we face significant challenges in navigating the current regulatory landscape. Our primary objective is to make the regulatory framework more predictable and efficient to support innovation while maintaining high standards for patient safety. We've identified several areas for improvement to create a more proportional and streamlined system.

The Bundesverband Medizintechnologie e.V. (BVMed) fully welcomes the European Commission’s ambition to streamline and future-proof the legal framework by reducing administrative burdens and increasing predictability and cost-effectiveness, while maintaining a high level of public health and patient safety, thereby contributing to the original objectives of the Regulations.

Filed in German · English published by the European Commission

We appreciate the Commissions initiative to revise the MDR rules and appreciate the opportunity to participate in this Call for Evidence. As a mid-size company with over many medical devices sold in the EU, we are experiencing an unprecedented burden on our resources, time and expense due to the increased requirements under MDR and cost of the certification.

We are fully supportive of the European Commissions initiative to simplify and streamline the IVDR, ensuring proportionate requirements while maintaining patient safety. Based on our experience, we highlight the following key challenges, particularly for Class B IVD devices: Sampling Burden: Current IVDR sampling rules (Annex IX, MDCG 2019-13) require 100% review of small portfolios (<5 devices), leading to repeated…

Amgen welcomes the Commissions efforts to undertake targeted simplification measures for the MDR and IVDR. For drug device combination products (DDC), we see three main opportunities for efficiency gains: 1) Non-integral products (intended to be used exclusively with a medicinal product): Under current legislation, integral devices (e.g., prefilled syringes) are reviewed mainly by medicines authorities with limited…

SPFDM/Euro-Pharmat thanked the Commission for this call for evidence and for the announced objectives of the forthcoming revision of the current rules on medical devices. With regard to these objectives, I would like to refer in particular to the following remarks: 1. With regard to the reporting obligations, we hope that the implementation of EUDAMED will facilitate these steps for economic operators.

Filed in French · English published by the European Commission

COCIR welcomes the attention raised by the European Commission on the shortcomings in the implementation of Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR). We commend the European Commissions intention to table a legislative proposal by end of 2025 to reduce the administrative burden, enhance the predictability and cost-efficiency of the certification processes of Notified Bodies, streamline…

It is reassuring that the commission recognises challenges with the implementation of the MDR and IVDR and it is a great opportunity to be able to provide feedback. The changes to regulations should improve patients safety and based on historical events, a change to MDD/IVDD was required.

We welcome the Commissions initiative to simplify EU regulations for in vitro diagnostics, while safeguarding both patient safety and fostering innovation. First of all, we fully support the urgent call opinion paper by Cobbaert et. al (https://doi.org/10.1515/cclm-2025-1033).

3 of 3: According to Medtech Europe, SME's make up 90% of medical technology companies in Europe. A 2023 Finnish study indicated that around 45% of health technology companies are micro-enterprises (fewer than 10 persons, turnover <2 million Euros) (https://pmc.ncbi.nlm.nih.gov/articles/PMC10062684/).

2 of 3: According to Medtech Europe, SME's make up 90% of medical technology companies in Europe. A 2023 Finnish study indicated that around 45% of health technology companies are micro-enterprises (fewer than 10 persons, turnover <2 million Euros) (https://pmc.ncbi.nlm.nih.gov/articles/PMC10062684/).

Issues experienced by the Dutch Association of Medical Microbiology (NVMM): 1. Availability of commercial diagnostic tests (i.e., especially the less profitable or low volume tests) is at risk and existing diagnostic tests disappear from the market due to: Additional costs and work for manufacturers due to the significantly increased regulatory burden.

Filed in Dutch · English published by the European Commission

1 of 3: According to Medtech Europe, SME's make up 90% of medical technology companies in Europe. A 2023 Finnish study indicated that around 45% of health technology companies are micro-enterprises (fewer than 10 persons, turnover <2 million Euros) (https://pmc.ncbi.nlm.nih.gov/articles/PMC10062684/).

Our biggest concerns are that there is a lack of consistency between Notified Bodies and between auditors in their interpretations of classification, labeling, PMS, and Clinical Evaluation requirements leading to excessive delays and costs.

We are a legal manufacturer of medical device software (MDSW), focused on clinical decision support tools ranging from simple calculators (e.g., CHADS-VASc) to machine learningbased algorithms. We currently market over 20 CE-marked products in the EU. As an SME, we have shown that compliance with MDR and IVDR is feasible even with limited resources.

We would like to draw your attention to a potential problem related to the direct UDI marking on certain medical devices and the definition of the reuse of these MDs. Due to the absence of a definition of reusable products, which differ only from single-use products within the meaning of Article 2 (8) of the MDR, medical devices regularly washed at home after use on a single patient (such as stockings/compression…

Filed in French · English published by the European Commission

Drawing on 30 years of experience (QSM and Technical Director under MDD, now Technical Director/Managing Director working for MDR) across five major product lines and multiple generations, I consider MDR to be the greatest "own goal" the EU could have scored against its own medical device industry. The variation in interpretation and intensity between Notified Bodies is not obviously regulated and deeply unfair.

Our feedback relates to ortheses and compression strips. For these products, the obligation of the UDI carrier on the product itself is technically impossible because it is impossible for us to trick the UDI carrier directly on our compressor products.

Filed in French · English published by the European Commission

* It should be made clearer in the MDR what happens to the manufacturer’s liability in case of bankruptcy of the manufacturer. Who is responsible for any investigations on products placed on the market and who is responsible for ongoing safety notifications (FCSA)? * Clarification concerning the lifetime of the product, especially for products intended to be used in the home environment.

Filed in Swedish · English published by the European Commission

As a manufacturer committed to delivering patient solutions across EU markets, we face several challenges under the MDR that require urgent attention. The MDRs administrative demands are increasingly burdensome, especially with the phased implementation of EUDAMED.

To whom it may concern, Thank you for the opportunity to give feedback related to the new MDR guidelines. I represent a small German based distributor of niche medical devices primarily focused on orthopedics and spine surgery. We sell products from around the world for special indications in pediatrics and deformity correction. I have over 30 years of Global Medtech experience managing large and small companies.

The MDR is highly strict, and its interpretation and enforcement have resulted in significant increases in certification costs, particularly for smaller manufacturers, which can threaten innovation and market access. The requirements for clinical evaluation have become extensive, often demanding additional clinical studies and evidence even for well-established or low-risk devices.

Thank you for the opportunity to provide feedback for the targeted revision of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). We support the Regulation's goal of ensuring a high level of safety and health.

As a manufacturer of medical devices already holding an MDR certificate for our products, we can state that Regulation (EU) 2017/745 has introduced chaos and significantly complicated the conformity assessment process, while at the same time failing to raise the level of product safety in line with the original intention behind the introduction of the MDR.

Areas were we as a manufacture see the need for improvement in order for EU to be a leading market: A centralized coordination to achieve better alignment between Competent Authorities in member states as well as Notified bodies with fixed timelines for review and fees would create a more predictable review process.

As the IT department of a health institution, we want to highlight two critical issues that the Commission should address in its revision of the MDR: 1) Adjustment of software risk classification (MDR Annex VIII, Rule 11). The current risk classification for software does not accurately reflect the actual patient risks and has the potential to hinder Europe's innovation capacity.

Review of European rules on medical devices and recommendations of the first French trade union of surgeons – dentists (Les Chirurgiens-dentists de France) Les CDF – Les Chirurgiens-dentistes de France – first French trade union welcome the revision announced by the Commission, sharing a patient safety lobjective while supporting innovation and competitiveness.

Filed in French · English published by the European Commission

A.I.S.E., the detergents sector association representing the European cleaning and maintenance products industry, thanks the European Commission for the opportunity to provide input to the call for evidence on a targeted revision of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This legislation is relevant to A.I.S.E.

IVD medical devices provide measurement results which contribute to medical decisions for patient treatment. These devices need to be accurate and IVD-MDs from different suppliers worldwide delivering their products into the European market should provide equivalent results for the same laboratory test to ensure safety and correct patient treatment.

Implandata GmbH Feedback on the Targeted Revision of the MDR Implandata welcomes the Commissions initiative to simplify and streamline the MDR. The way the MDR has been implemented places a disproportionate burden on SMEs and innovative companies. The result is delayed access to life-saving technologies, shrinking European competitiveness, and increasing device shortages. 1.

Summary of SME Feedback on IVDR Revision General Position IVDR implementation has created duplications, disproportionate burdens, skyrocketing costs, and inconsistent interpretations. These issues especially affect SMEs transitioning into Class C/D products.

I am a representative of a small company which produces medical devices in a technology known for many years, has been developed in the course of implementing the requirements of the MDD Directive into Polish regulations and is still being implemented under the MDR transitional period, with minor changes.

Filed in Polish · English published by the European Commission

We are an SME with SaMD devices (Class IIa), and for more than 30 years, we have been engaged in the development, manufacture, and marketing of our medical devices as an SME. One of our devices was MDR certified in June 2024 after an approval trajectory of over 2 years! Another device is currently undergoing MDR certification (submitted November 2024, first technical review to be received).

Generative AI in care is largely covered by the MDR in class IIa or above, because the classification is based on the potential severity of harm and hardly takes into account the likelihood of such harm occurring. As a result, applications with relatively low real risk also have a heavy trajectory with Notified Body assessment, extensive clinical evidence and a tight quality management system.

Filed in Dutch · English published by the European Commission

Feedback on the current IVDR and proposal for change on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by their Committee European Regulatory Affairs chaired by Prof. Dr. Christa Cobbaert of its Division of Quality, Standards and Regulations, chaired by Prod. Dr.

The Dutch Society for Clinical Chemistry and Laboratory Medicine (NVKC) welcomes the Commission's initiative to revise the IVDR and appreciates this opportunity to contribute our expertise in laboratory diagnostics throughout the Netherlands.

In order to make the IVDR more effective, it is necessary to simplify the transition of devices already on the market by self-certification under the IVDD. A simplified and accelerated procedure based on the history of such devices (e.g. number of incidents reported) and manufacturer (e.g. ISO 13485 certification) should enable IVDR certificates to be obtained almost automatically.

Filed in French · English published by the European Commission

The purpose of regulation is to ensure patient safety and guarantee the performance of MD. While this is indisputable, experience has shown that the regulation does not promote the supply of innovative or improved MD within timeframes compatible with the needs of healthcare professionals, patients and technology improvements. Certification obtention required delay and a significant financial and human investment.

Without prejudice to the requirements relating to the appropriate level of safety according to the level of risk of the arrangements, simplification, with a view to reducing the administrative work of all actors, shall be given priority.

Filed in French · English published by the European Commission

On behalf of six associations: Pharma Deutschland Spitzenverband Digitale Gesundheitsversorgung Medical Valley Eurocom Digital Therapeutic Alliance vfa Die forschenden Pharma-Unternehmen we respectfully request a revision of MDR Rule 11.

We are a small company (30 people) that has been MDR certified since June 2024. What an adventure! Two years of effort and two years spent tripling the amount of documentation produced (oftern without addins value), constantly answering questions from auditors who generated increasingly lengthy reports (a total of four reports of around 300 pages) for two medical devices, working in a manner worthy of the largest…

As a small Danish medtech company, we would like to share our concerns regarding the implementation of the EU Medical Device Regulation (MDR). While we support the intention of ensuring patient safety and product quality, the way MDR currently functions poses serious challenges for small and medium-sized enterprises like ours. Excessive Costs: The cost of compliance is extremely high and disproportionate for SMEs.

Article 52, paragraph 6 MDR and Annex IX, Chapter I, Section 3.5 specify the assessment of technical documentation on the basis of representative samples. The sampling shall take into account the MDCG-Guideline, the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any relevant previous assessments, e.g.

We think that: — lifespan, MDR and reprocessing need to be reviewed: the regulatory framework should support reprocessing to a greater extent, outside the lifetime period. It also promotes sustainability and environmental objectives, in addition to its positive economic effects. — it should not be a special adaptation when assembling spectacle frames with personalised lenses for visual correction.

Filed in Swedish · English published by the European Commission

As a QAR manager in an SME with 50 people and a microstructure of 5 people, one of the main problems related to the settlement of medical devices is that regulations apply indiscriminately to all DM, including all existing products. This results in a delay in the processing of dossiers, which has been regretted by both manufacturers and notified bodies, and an enormous administrative burden for all actors.

Filed in French · English published by the European Commission

The In Vitro Diagnostic Regulation (IVDR) represents an important milestone in strengthening patient safety in the field of in vitro diagnostics. However, its current design has resulted in excessive bureaucracy, limited transparency, and significant delays in market access across many areas.

The MDR was built without having an idea of the consequences for each of the economic operators (e.g. at the end of 2024, the NAOs did not yet know how to audit the distributors!) and the time that the adaptation will take.

Filed in French · English published by the European Commission

From the SME perspective, the current legislative framework leaves too much room for individual interpretation. This becomes especially problematic when SMEs hire consultants to support the certification process. Often, consultants have experience with one Notified Body, but their approach is not accepted by another.

The scope and technical functionality of Eudamed should be expanded to collect additional medical device nomenclature codes including, but not limited to, GMDN. This would bring several benefits, including: Supporting reliance processes and the ability to accept submissions in a common harmonised format to support streamlined registration and UDI data collection Availability of high resolution and up-to-date…

The requirements of the IVDR regarding the use of in-house methods (IH-IVD) do not fit with the tasks of national reference centres and consiliar laboratories (NRAs, KLs) and other state health laboratories. These laboratories are primarily engaged in surveillance of the most relevant pathogens and thus serve primarily public health, not the individual patient.

Filed in German · English published by the European Commission

Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments on the targeted evaluation by the Commission on the EU rules for medical devices and in vitro diagnostics. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures.

As a major German manufacturer specializing in wound care medical devices we welcome the Commission's initiative to streamline the regulatory framework while maintaining high safety standards. We fully support the BVMed/VDGH Whitepaper Future Development of the MDR and IVDR regarding the urgent need for MDR/IVDR revision, especially the need for better predictability and timely feedback from Notified Bodies.

The German, Austrian and Swiss Poison Centres forming the working group II of the Society of Clinical Toxicology (GfkT) offer around the clock advice in cases of suspected poisoning, thereby enabling rapid and targeted medical treatment of patients. GfkT has noted the impact of the In Vitro Diagnostic Regulation (IVDR; EU-Regulation 2017/746).

As an SME manufacturing an older medical device, we face significant challenges with the implementation of the MDR. 1. Costs and administrative burden The costs of MDR certification are exorbitant, particularly for SMEs.

To whom this may concern, PHOENIX group welcomes the commitment of the European Commission to revise EU rules on medical devices and in vitro diagnostics. We especially welcome the focus of the targeted revision on protecting patient health whilst making the medical device sector more agile in a challenging global environment.

1. The costs for MDR certification are extremely high, creating a major barrier for startups and small businesses. Prices also vary significantly between different Notified Bodies, with little transparency on what justifies these differences. 2. Time-to-market in the EU has not improved with the introduction of the MDR. In fact, it has worsened.

Our laboratory primarily uses lab-developed (LDTs). With regard to the requirements for LDTs, the IVDR should be revised as a matter of urgency: 1. Harmonisation with the requirements of international standards (in particular DIN EN ISO 15189): Harmonisation would ensure, on the one hand, that many items from Annex 1 become applicable and, on the other hand, that the necessary documentation could be streamlined. 2.

Filed in German · English published by the European Commission

Feedback on the Revision of the IVDR As an employee of a small and medium-sized enterprise (SME) in the field of in vitro diagnostics (IVD), I strongly support the revision of the IVDR. The current regulatory framework poses significant challenges for smaller manufacturers and threatens the competitiveness and innovation capacity of European companies. 1.

There are several gaps in MDR; to date, the Notified Bodies have a long time, high cost and focus only on formal aspects. Some simplification/harmonisation proposals are as follows: (1) Clinical evaluation: the requirements for clinical evaluation remain unclear, especially for very simple and well-established products representing 90 % of products such as needles, patches, flowers; it should be clearly stated that…

Filed in Italian · English published by the European Commission

We, as SIDIV, the French national association for IVDs, thank the European Commission for this initiative to improve the regulatory system for IVDs and ensure European citizens and health systems continue benefiting from safe, high-performing and innovative IVDs.

While regulating the safety of medical devices in the European market is essential, we are concerned about the interpretation of the Medical Device Regulation (MDR) regarding low-risk digital calculators. Despite several borderline manuals published in recent years, the interpretation remains ambiguous and inconsistent. Consequently, classification varies across EU countries notified bodies.

On behalf of the Dutch Poison Information Centre, a non-profit governmental institute, we would like to highlight the challenges that the Medical Device Regulation (MDR 2017/745) creates for niche software applications. Our Centre provides a simple online calculation tool to support medical professionals in the treatment of poisoned patients.

The feedbacks mainly concern Class 1 devices. MDR has reduced the supply of medical devices/innovations for some product areas. As we see, access to simpler and new class 1 products on the market is reduced as a result of the increased administrative scale and significant financial effort. The assessment is also that technological life has become more decisive for the reuse of assistive devices.

Filed in Swedish · English published by the European Commission

(a) postpone EUDAMED to the end of 2027 & 2028 in line with the end of the transitional periods. For example, there is no longer a need to include legacy products in the database. b) update of CER, PSUR & SSCP 1x a year for MPs (high risk), even if MPs do not change & remains safe.

Filed in German · English published by the European Commission

As an EU Authorized Representative, we although recognize the benefits of the stricter white labelling rules under MDR and IVDR, such as improved patient safety, transparency, and clearer manufacturer accountability.

The current Medical Device Regulation (MDR) has introduced a level of complexity that undermines its intended objectives. A more effective course of action would be to suspend its implementation, reinstate the previous MDD framework as a transitional measure, and relaunch the reform process with a stronger evidence base.

Targeted legislative adjustments can be useful in achieving the objectives of the MDR and IVDR, also in view of the considerable difficulties manufacturers and notified bodies faced during the transition from the previous legal framework.

MDR has complicated things to a burdensome level for legacy class I products. Products intended for intact skin and being on the market with no problems for decades are now burdening the companies and notified bodies alike. Low risk products are overregulated in vein with absolutely nothing to gain. Risk management should be continued with the post market surveillance by the company itself.

We represent the National Institute of Public Health and the Environment (RIVM). As a public health laboratory with ISO 15189 accreditation, we address the following issues, particularly with a focus on more rare infectious diseases, to fill laboratory gaps across the country or to support other diagnostic laboratories.

Unfortunately, Switzerland has taken over the overregulated MDR with all the consequences. As a manufacturer of an IIa medical device which has not been the subject of a single adverse reaction report for more than 10 years, we do not understand why it is treated in the same way as pacemakers or implants.

Filed in German · English published by the European Commission

I am a researcher, and I see that many clinical conditions urgently require more basic research to improve our understanding of disease mechanisms. In some cases, specialized technical equipment is necessary to enable this type of research. In these situations, the equipment itself is not the subject of study; rather, the focus is on the underlying clinical condition.

The Austrian Chamber of Commerce welcomes the initiative to simplify EU rules on medical devices and in vitro diagnostic medical devices. The implementation of the MDR and IVDR has led to high requirements for all economic operators. There has been a huge increase in both the bureaucratic and financial burden on entrepreneurs. In general, the requirements are very complex and require a high level of expertise.

Filed in German · English published by the European Commission

Per EU MDR 2017/745, there is a list of exemptions listed for implanted devices that do not require an Implant Card. There is a lot of information throughout MDR regarding devices that remain in place for <30 days. Would the European Commission consider the addition of these types of devices to the list of exemptions in Article 18.

This contribution aims to propose the explicit inclusion of dental bleaching agents with concentrations above 6 % hydrogen peroxide (or equivalent compounds that release hydrogen peroxide) in medical devices under Regulation (EU) 2017/745 (MDR) in the context of the ongoing targeted review.

Filed in Portuguese · English published by the European Commission

This contribution aims to propose the explicit inclusion of dental bleaching agents with concentrations above 6 % hydrogen peroxide (or equivalent compounds that release hydrogen peroxide) in medical devices under Regulation (EU) 2017/745 (MDR) in the context of the ongoing targeted review.

Filed in Portuguese · English published by the European Commission

This contribution aims to propose the explicit inclusion of dental bleaching agents with concentrations above 6 % hydrogen peroxide (or equivalent compounds that release hydrogen peroxide) in medical devices under Regulation (EU) 2017/745 (MDR) in the context of the ongoing targeted review.

Filed in Portuguese · English published by the European Commission

For standard of care, legacy passive implantable devices, comparable in clinical use to the WET devices, current post-market requirements are overly burdensome, and we would like to advocate an update that scales post-market obligations for passive implantable, legacy standard-of-care devices that are WET-analogous (e.g., tissue markers, fiducial markers).

For children and adolescent medicine (child cardiology, neonatology, paediatric intensive medicine, dialysis in children) products have been used for many years, the further availability of which is at risk by the MDR. These are either products that are to be manufactured cheaply but only in small numbers (e.g. dialysis catheters) or products authorised for use with adult patients (e.g.

Filed in German · English published by the European Commission

We appreciate the Commission's initiative to simplify EU regulations for in vitro diagnostic (IVD) medical devices. Firstly, as has been pointed out, the cost of certification has risen exponentially for SMEs. This is reflected in notified body (NB) fees - both pre- and post-market - and the significant human resources required for data collection.

As the umbrella organisation of German hospitals in public, non-profit-making and private ownership, the German Hospital Company (DKG) has been participating constructively in health policy discussions at EU level for many years. DKG expressly welcomes the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics (IVDR) Regulation announced by the European Commission.

Filed in German · English published by the European Commission

As a start-up medical device company the process is quite challenging. However, the tools provided, including Help Desk, are very good. The documentation and maintenance are time consuming. The aims of the MDR are noble and improve safety. The licensing costs are high compared to the MDD. This needs to be addressed and the licence cost should be related to company sales of devices.

I'm representing the Dutch IVDR taskforce in which representatives of medical diagnostic laboratories working in the field of clinical chemistry, immunology, microbiology, pathology, genetics and pharmacy work together to advise diagnostic laboratories in the Netherlands on how to implement IVDR for laboratory-developed tests.

I'm representing the Dutch IVDR taskforce in which representatives of medical diagnostic laboratories working in the field of clinical chemistry, immunology, microbiology, pathology, genetics and pharmacy work together to advise diagnostic laboratories in the Netherlands on how to implement IVDR for laboratory-developed tests.

One of the problems with the MDR is the extremely high cost of certification and the assessment of technical documentation. The costs have at least doubled since the switch from the MDD to the MDR. The significant increase in external costs is due to increased internal costs due to the increased documentation burden.

Filed in German · English published by the European Commission

Dear Members of the Commission, Assogastecnici, part of Federchimica, is the association of companies active in the production and distribution of technical, specialty, and medicinal gases. Its member companies represent the entire national market and employ approximately 5,000 people, generating a turnover of approximately 2.6 billion.

Call for proportionate regulation: Accelerating innovation for life-saving devices, maintaining strict controls for high risk cosmetic implants Our patient organisation supports the review of the regulatory framework for medical devices, with the aim of speeding up innovation and reducing bureaucracy.

Filed in Dutch · English published by the European Commission

We welcome the Commissions initiative to revise the EU rules for medical devices and appreciate the opportunity to participate. Regarding the Clinical Evaluation Report (CER): Currently, regardless of the medical device classification or whether it is considered a Well Established Technology (WET), an extensive and highly detailed submission of information is required.

1. Reduce the administrative burden The requirements for clinical investigations/perfomance studies should be made more risk-proportionate Notified Body conformity assessment should be streamlined and mandatory recertification should be discontinued Post-market surveillance reporting should be made more risk-proportionate o PMS obligation also applies, under Article 120, to devices manufactured as MDD during the…

Heated Community Hub (HCH), a non-profit association committed to promoting public health and tobacco harm reduction, welcomes the European Commissions initiative to carry out a targeted revision of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).

Eurocom welcomes the European Commission’s initiative to make rapid changes to the MDR with the aim of simplifying and strengthening the competitiveness of economic operators in relation to medical devices, as well as making the regulations more proportionate. Eurocom considers it very positive that the European Commission is paying particular attention to the concerns of small and medium-sized enterprises (SMEs).

Filed in German · English published by the European Commission

Leaseurope, the voice of leasing and automotive rental at EU level would like to draw the Commission's attention to an issue of key importance for the leasing industry, which could prove material for the availability of medical devices on the EU market.

The Regulation on Medical Devices represents a disproportionate burden for both manufacturers and notified bodies, without, however, having a major impact on the safety and performance of products already on the market. And sometimes even, these new requirements have the opposite effect by no longer protecting the European patient!

Filed in French · English published by the European Commission

I'm representing the Dutch IVDR taskforce in which representatives of medical diagnostic laboratories working in the field of clinical chemistry, immunology, microbiology, pathology, genetics and pharmacy work together to advise diagnostic laboratories in the Netherlands on how to implement IVDR for laboratory-developed tests.

There is little consideration for SME's and the administrative burden that the EU MDR has caused. Maintenance of EUDAMED and UDI labelling requirements alone are a huge extra burden for small manufacturers. As a small manufacturer of multiple low risk class 1 devices but essential dental consumables we are having to put a huge amount of resource now in to maintaining extra systems due to the amount of individual…

The mentioned initiative to update, review and improve the current IVDR regulation would be highly important. The current approach has significant constraints for the healthcare systems, innovation and economical position of the European Union in global competition.