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

Thank you for allowing us to comment on the proposed MDR Revision text. There are some great revisions which have been done to the MDR regulatory framework. Thank you. Here are my recommendations (also within attached PDF) based on my long-time working experience in medtech as technical file & clinical evaluation writer & evaluator, as RA/ QMS/ Clinical Affairs manager and as senior biomedical engineer working for…

MDR/IVDR Targeted Revision (COM(2025) 1023): Dedalus, a European healthcare software group (7,000+ employees, standalone software medical devices used by hospitals across the EU), welcomes the Commission proposal as a strong basis for restoring proportionality, predictability and international competitiveness while maintaining patient safety.

Scarlet is a Dutch notified body specialising in AI and standalone software medical devices, designated under Regulation (EU) 2017/745. We strongly support the objectives of this reform to improve the predictability and speed of the conformity assessment process, and welcome the Commission's efforts to better adapt the MDR framework to the realities of software and AI.

We very much welcome the aim of the Commission’s proposal to simplify the MDR/IVDR without compromising the level of protection of patient safety and public health. From the point of view of academic research, university medicine and publicly funded collaborative research, it is crucial that the planned relief measures are implemented in a risk-appropriate manner and target areas where current practice has been…

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SVDGV Statement: Ensuring Legal Certainty and Proportionality in the Classification of Software and AI-Based Medical Devices (MDR Reform, Annex VIII, Rule 11) The German Digital Healthcare Association (SVDGV) welcomes the Commission's proposal (COM(2025) 1023 final) to simplify the MDR and align software risk classification with actual patient risk. We raise two concerns: 1.

Cardinal Health welcomes the opportunity to provide feedback on the proposed targeted revision of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), particularly the proposed amendments relating to Article 17 and the regulation of reprocessed medical devices.

VPH Society Position on In Silico Evidence in the revised MDR The Virtual Physiological Human (VPH) Society representing the scientific community strongly supports the explicit inclusion of in silico evidence (computational modelling, simulation, and New Approach Methodologies) across the medical device lifecycle in the revised EU MDR.

Stryker welcomes the European Commission's targeted revision of the MDR. The proposal represents an important step toward creating a more efficient and predictable regulatory framework while maintaining the high standards of patient safety that remain central to the European medical technology ecosystem.

Marsi Bionics is a European SME developing first-in-class paediatric rehabilitation robotics. We welcome the targeted revision of the MDR and its aim of reducing disproportionate costs and delays while preserving patient safety.

We are a small European supplier of clinical software. We support the overall direction of the proposed revision, including the simplified documentation requirements, the removal of the IVDR equivalence condition, the new transfer possibility for preparedness, and the restructuring of Rule 11. Our comment is narrow: it concerns the MDR only, and within it only devices consisting of software.

PETA Science Consortium International e.V. (the Science Consortium) welcomes the opportunity to comment on the European Commission (EC) proposal for a Regulation of the European Parliament and the Council amending Regulations (EU) 2017/745 on medical devices, 2017/746 on in vitro diagnostic medical devices, 2022/123, and 2024/1689.

On behalf of the joint EFOMP/ESTRO/ESR/EANM working group Software as a Medical Device (MDSW) in Medical Physics we would like to comment on the targeted revision of the MDR. As Medical Physics Experts (MPEs) working in hospitals, our members play a key role in ensuring the safe, effective, and appropriate use of medical technology (hardware and software).

Global D welcomes the European Commissions initiative to simplify and improve Regulation (EU) 2017/745 (MDR), recognizing its potential to reduce unnecessary regulatory burdens while preserving the high standards of safety and performance that underpin the European medical device framework.

AVDZP Association of Manufacturers and Suppliers of Medical Devices (Czech Republic) welcomes the targeted revision COM(2025) 1023 and its aim to simplify the framework, reduce administrative burden and support timely patient access to innovation, while preserving safety. A detailed position paper covering 30 priority areas is attached; the key points are summarised below.

Dear EU-Commission, TÜV Rheinland, welcomes the Commissions objectives to enhance efficiency, predictability and innovation within the MDR/IVDR framework. The proposed emphasis on digitalisation, risk based surveillance, reduction of unnecessary administrative burden, improved support for SMEs, and niche devices is an important step towards a more modern and agile regulatory system.

The Polish employers strongly support the direction of the revision of Regulation (EU) 2017/745 (MDR) and actions aimed at increasing the efficiency of the European regulatory system for medical devices. We believe that the changes should foster faster patient access to innovative health technologies, while maintaining high standards of safety and quality of medical devices.

Filed in Polish · English published by the European Commission

Dansk Erhverv (The Danish Chamber of Commerce) welcomes the opportunity to provide feedback to the European Commissions proposal for a revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). We look forward to a continued and constructive engagement with the Commission as the legislative process progresses.

NVZ response to the MDR/IVDR amendment, 3 August 2026 Introduction Although the MDR and IVDR make important contributions to patient safety, the current rules have also led in practice to reduced availability of medical devices and diagnostics, increased implementation burden for healthcare institutions and insufficient transparency on clinical performance of products.

Filed in Dutch · English published by the European Commission

Following our initial contribution to the Commissions consultation (https://medicalmountains.de/wp-content/uploads/2026/04/202604_MDR-Revision-Proposal_Positions-MedicalMountains_1_1_EN.pdf), MedicalMountains GmbH would like to submit a set of additional, article-specific amendment proposals.

DiaLab welcomes the opportunity to provide feedback to the European Commissions proposal for a revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). DiaLab is a Danish industry association for companies who are manufacturers and/or distributors of in-vitro diagnostic devices as well as laboratory equipment.

In response to the European Commissions proposed amending regulation, and based on the input from its members - particularly Austrian public hospital providers - the VÖWG has formulated feedback and amendment proposals. The document is attached below.

The German Chamber of Commerce and Industry welcomes the proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 with a view to simplifying the rules on medical devices and in vitro diagnostic medical devices.

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AbbVie welcomes the Commissions targeted revision of the MDR/IVDR and appreciates the intent to update Regulation (EU) 2017/745 based on practical experience and broadly supports many of the Commissions proposals. These proposals introduce important measures to support innovation and improve regulatory efficiency, however, there is room for further improvement on several aspects.

As a micro-enterprise, we welcome the Commissions proposal. A risk-based approach that moves away from rigid quotas in market surveillance towards a for cause approach. Even though a specific justification is required for an unannounced audit or sampling by the notified bodies, this approach nevertheless leads to a greater focus on actual risk. For cause does not mean that something must have happened first.

CE Certiso welcomes the Commissions proposal to amend Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). We agree that several measures are necessary to improve the system, such as the regulation of breakthrough and orphan devices, digitalization, and enhanced regulatory cooperation.

The National Measurement Laboratory (NML) at LGC welcomes the Commission's initiative to simplify the regulatory framework for medical devices and IVDs. We support efforts to reduce unnecessary regulatory burden while maintaining high standards of patient safety, innovation and trust.

(AFIDEO: Association des Fabricants Importateurs Distributeurs Européens d’implants Orthopédiques & traumatologiques) The most impacting point of the proposal is the relaxation of the rules for the use of equivalence for the clinical evaluation of new MDs: deletion of contract terms where the DM already marketed is manufactured by a third party, and the concept of ‘similarity’ for biological and clinical…

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COCIR welcomes the Commission proposal for a targeted revision of the Regulation (EU) 2017/745 and supports its overarching objectives: maintaining a high level of patient safety and public health, while reducing unnecessary administrative burden, improving the predictability and cost-efficiency of conformity assessment, strengthening digitalisation, and international cooperation.

The Blood Transfusion Association (BTA) MDR Working Group, comprising Cerus, Fresenius, GVS, Haemonetics and Terumo BCT, supports the European Commissions efforts to simplify the Medical Devices Regulation (MDR) while safeguarding patient safety and ensuring the uninterrupted supply of blood products across Europe.

Cruelty Free Europe welcomes the opportunity to provide feedback on the European Commissions adopted act for the initiative Targeted revision of the EU rules for medical devices and in vitro diagnostics. We support the aim of this initiative to streamline and future-proof the regulatory framework for medical devices and in vitro devices.

ADKA welcomes the targeted revision of the MDR and IVDR. We propose that Article 5(5) of both Regulations explicitly permit pharmacies, as health institutions, to prepare substance-based medical devices and in vitro diagnostic medical devices in limited, non-industrial quantities, including preparation in advance for stock.

The European Society of Radiology (ESR), representing over 140,000 members both in and out of Europe, welcomes the European Commissions proposal to simplify EU rules for medical devices and in vitro diagnostics.

We appreciate the opportunity to provide feedback on the proposed revision of the EU Medical Device Regulation, and we are broadly supportive of the objectives underpinning the revision. As a manufacturer of Software as a Medical Device (SaMD), we recognise the importance of ensuring patient safety while fostering innovation and the availability of medical software solutions.

ResMed welcomes the European Commission's targeted revision of Regulation (EU) 2017/745 (MDR) and strongly supports its objectives of strengthening the regulatory framework while improving efficiency, predictability and timely patient access to safe and innovative medical technologies. Overall, ResMed considers the proposal to be a positive step towards a more proportionate and future-ready regulatory system.

This initiative seeks to simplify EU rules for medical devices and in vitro diagnostics. It aims to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare.

Filed in Italian · English published by the European Commission

The European Organisation for Research and Treatment of Cancer (EORTC) welcomes the European Commission's initiative to simplify the regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). The proposed amendments represent an important opportunity to reduce unnecessary regulatory complexity while maintaining the EU's high standards for patient safety and public health.

Centre for SMART Comment on the proposed amendment to Article 17 of the EU MDR The Centre for Sustainable Manufacturing and Recycling Technologies (SMART) at Loughborough University in the UK led a pioneering research project on The Circular Economy of Small Medical Devices from 2022-25 and is continuing that work in further projects.

On behalf of Institut Pasteur (FR), including its network of National Reference Laboratories (NRLs), we warmly welcome the proposed amendments to the In Vitro Diagnostic Medical Devices Regulation (IVDR) and strongly support their incorporation into the revised regulatory framework.

This note is jointly supported by the European Society for Brain Stimulation (ESBS) and the Brain Stimulation Special Interest Group (BS-SIG) of the International Federation of Clinical Neurophysiology (IFCN). FIVE points are submitted as separate comments due to character limitations.

This note is jointly supported by the European Society for Brain Stimulation (ESBS) and the Brain Stimulation Special Interest Group (BS-SIG) of the International Federation of Clinical Neurophysiology (IFCN). Together, these societies represent a significant number of medical professionals, clinicians, and researchers across Europe, who work with medical devices and related neurotechnology in humans, in particular…

This note is jointly supported by the European Society for Brain Stimulation (ESBS) and the Brain Stimulation Special Interest Group (BS-SIG) of the International Federation of Clinical Neurophysiology (IFCN). Together, these societies represent a significant number of medical professionals, clinicians, and researchers across Europe, who work with medical devices and related neurotechnology in humans, in particular…

This note is jointly supported by the European Society for Brain Stimulation (ESBS) and the Brain Stimulation Special Interest Group (BS-SIG) of the International Federation of Clinical Neurophysiology (IFCN). Together, these societies represent a significant number of medical professionals, clinicians, and researchers across Europe, who work with medical devices and related neurotechnology in humans, in particular…

This note is jointly supported by the European Society for Brain Stimulation (ESBS) and the Brain Stimulation Special Interest Group (BS-SIG) of the International Federation of Clinical Neurophysiology (IFCN). Together, these societies represent a significant number of medical professionals, clinicians, and researchers across Europe, who work with medical devices and related neurotechnology in humans, in particular…

Medtronic welcomes the European Commission's targeted revision of the Medical Device Regulation (MDR) and supports its overarching objectives to strengthen the European regulatory framework while improving its efficiency and predictability.

This feedback is submitted by the Norwegian specialist healthcare service. The four regional health authorities wish to regain access to external reprocessing under full manufacturer responsibility, forfeited when Norway chose not to opt in on the MDR's introduction after more than a decade of such practice at Oslo University Hospital (5,400 CE-marked reprocessed devices used in 20102022 without reprocessing-related…

Christian Council International commends the European Commission for its call for input related to amending Regulations 2017/745, 2017/746, 2022/123 and 2024/1689. While we acknowledge the need for reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, we wish to highlight that these reductions should not impact the inherent human dignity of all human beings and their…

FENIN (Federation of Health Technology Companies) represents companies providing health technology throughout the national health system in Spain, encompassing around five hundred companies in both hospital and primary care consumer products, as well as in pharmacies, dental clinics, orthopaedic surgeries, audio-prostheses cabinets and even consumer products including, inter alia, diagnostic, monitoring or therapy…

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Veeva MedTech supports the European Commissions targeted simplifications to Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), emphasizing that delivering long-term predictability and operational relief requires a modern, system-agnostic digital architecture.

As a consultant with many years of experience in the medical device industry particularly for small and medium-sized manufacturers and startups I welcome the European Commissions proposal to simplify the regulatory framework for medical devices. Overall, the proposed changes are appropriate for easing the burden on small and medium-sized manufacturers and reducing their excessive administrative workload.

Proposed amendments to Article 61(5) in COM (2025) 1023 aim to remove the mandatory contractual requirement for demonstrating equivalence between medical devices. The change seeks to alleviate market access barriers, replacing the contract mandate with a requirement for clear evidence of technical compliance, while maintaining strict technical equivalence standards.

EssilorLuxottica welcomes the European Commission's initiative to modernize the regulatory framework for medical devices and encourages the inclusion of provisions enabling electronic Instructions for Use (e-IFU) as the default information format for eligible Class I and Class II medical devices intended for lay users.

Solventum is a global medical technology company with over 22,000 employees worldwide, including around 4,000 in Europe. It develops solutions in wound care, oral healthcare and digital health. The proposed MDR revision is a positive step toward greater efficiency, predictability, and proportionality. Additional refinements are required to support patient safety and timely access to innovation. 1.

TÜV SÜD Product Service GmbH (NB 0123) calls for a targeted MDR/IVDR revision that improves efficiency, predictability and competitiveness while preserving robust independent conformity assessment and patient safety.

Takeda Pharmaceuticals welcomes the opportunity to provide comments on the proposed changes to the medical device and in vitro diagnostic regulatory frameworks. Overall, we support measures that promote a more proportionate, risk-based, and harmonised regulatory system while maintaining robust standards for patient safety and device performance.

The British Dental Industry Association (BDIA) is the UKs national trade association representing and supporting the collective interests of manufacturers and suppliers of dental products, services and technologies.

The Norwegian Pharmacy Association, representing all community pharmacies as well as hospital pharmacies in Norway, submits this response on behalf of our members. We generally support the proposed changes and agree that they will make the rules for medical devices simpler and more effective. It will ensure high access to the products and a high level of patient safety.

The full DGPharMed and FFM position statement is given in the attached document. Executive Summary DGPharMed and FFM welcome the European Commission's proposal COM(2025) 1023 final as a timely and constructive response to the findings of the targeted evaluation of Regulations (EU) 2017/745 (Medical Device Regulation, MDR) and (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation, IVDR).

27-07-2026 ANFAO, Italian Association of Optical Goods Manufacturers, strongly supports amending Regulation (EU) 2017/745 (MDR) as regards simplifying and reducing the burden of the rules on medical devices and to allow manufacturers to provide electronic Instructions for Use (eIFU). Nevertheless, the current restriction of eIFU to professional users is no longer appropriate in a digital healthcare environment.

The 34 European Medical Societies that the BioMed Alliance represents believe that reform of the regulatory system is necessary, as some of the unintended consequences of the MDR and IVDR implementation led to high costs and reduced availability of essential devices and diagnostics .

SPECTARIS welcomes the European Commission's targeted MDR/IVDR revision as an important step toward a more workable, proportionate and innovation-friendly regulatory framework, one that keeps patient safety high while easing unnecessary burden on manufacturers, notified bodies and authorities.

The Snitem welcomes the proposal for a targeted revision of the Medical Devices Regulation. This initiative responds to several challenges identified since the entry into application of the Regulation and is an important step to restore the predictability of the European regulatory framework, strengthen patients’ access to innovations and support the competitiveness of the European medical technology industry, while…

Filed in French · English published by the European Commission

Cancer Patients Europe (CPE) welcomes the opportunity to comment on the European Commission's proposal to amend Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Medical devices and in vitro diagnostics are essential throughout the cancer pathway, from screening and diagnosis to treatment and follow-up.

Inspire feedback on the MDR reform The INSPIRE platform of the Mannheim Medical Faculty of the University of Heidelberg supports start-ups, companies and researchers in the field of medical technology in building clinical partnerships and early evaluation of innovations. The aim is to accelerate the transfer of new medical devices into clinical use. 1.

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I am the CEO of ESCRS which is a European based professional not-for-profit with over 7000 European ophthalmic surgeons as members and holding the largest annual ophthalmic conference globally (up to 18,000 attendees from over 160 countries). We would submit that we are broadly in agreement with the points already submitted on 13th July 2026 to MEP Oliver Schenk from the Dutch co-allition of ophthalmic surgeons.

The European Commission's proposed revision of the Medical Devices Regulation (MDR) marks an important step forward for European healthcare by requiring manufacturers to justify single-use labelling. This development reflects a long-standing call from healthcare providers and sustainability advocates to ensure that medical devices are reused when safe to do so.

IVDR/MDR revision: cautiously clarify a viable route from lab to practice When you are ill, you just want one thing: improve. Prefer to stay healthy. At a time when bespoke health is emerging thanks to advances in diagnostics, disease models and treatment options, hollandbio sees innovative diagnostics that help make bespoke work possible in practice as stumbling away from a forest of rules and procedures, including…

Filed in Dutch · English published by the European Commission

Cochlear welcomes the opportunity to comment on the EU Commissions proposal to strengthen competitiveness of the Medical Device sector and improve safety requirements by making them more cost-effective and proportionate Cochlear supports the MDR simplification objectives but recommends targeted amendments to preserve legal clarity, patient safety, and regulatory effectiveness.

The AIT Austrian Institute of Technology appreciates the efforts being made by the EU-Commission in its proposal to simplify and reduce the burden of the rules on medical devices and in vitro medical devices. The proposed amendments to reduce overregulation and fragmentation of the approval for medical devices and clinical investigations are urgently needed to guarantee optimal medical technology for the patients…

The reprocessing of single-use devices is regulated in detail in Regulation (EU) 1207/2020 (CS) and thus ensures their safe reprocessing. Compliance with manufacturer’s obligations does not provide any additional benefit in terms of patient safety, especially since CE-processed egg products can be freely offered on the market.

Filed in German · English published by the European Commission

TIC Council, as representative of the Testing, Inspection and Certification (TIC) industry, welcomes the European Commissions intention to simplify the EU MDR and IVDR. However, we are concerned that the strict wording of Annex VII concerning the governance of notified bodies could be interpreted as preventing larger TIC entities, or larger organisations as referred to in the MDR and IVDR, from operating notified…

CEN and CENELEC develop European Standards setting safety, quality, and performance requirements for medical devices that are put on the European market. A large number of those standards enable manufacturers to make their medical products compliant with the European legislation in the medical sector, for the ultimate benefit of all European citizens.

The Medical University of Graz welcomes the European Commission's initiative to reduce unnecessary regulatory complexity and improve the efficiency of the medical device regulatory framework, while ensuring a high level of patient safety.

What is JANE-2? JANE-2 (Joint Action Networks of Expertise in Cancer) is an ambitious initiative, stemming from Europes Beating Cancer Plan, with the aim to implement seven new European Networks of Expertise in different cancer conditions, addressing: 1) complex and poor prognosis cancers; 2) palliative care; 3) survivorship; 4) personalized primary and secondary prevention; 5) omics technologies, 6) hi-tech medical…

We welcome the revision of the Medical Devices Regulation (MDR) and would urge the European Commission to explicitly strengthen the quality-assured reprocessing of suitable single-use medical devices in accordance with Article 17 MDR and Implementing Regulation (EU) 2020/1207 (Common Specifications).

Filed in German · English published by the European Commission

Smith+Nephew (S+N) welcomes the opportunity to comment on the EU Commissions proposal to strengthen competitiveness of the Medical Device sector and improve safety requirements by making them more cost-effective and proportionate. S+N particularly supports the proposed measures on digitalisation (Article 52b) and reliance/recognition (Article 108).

Single-use justification: The proposal reverses the current approach justifying single-use medical devices. Under the proposed framework, a device may only be designated as 'single-use' if the manufacturer demonstrates that it cannot guarantee continued compliance with safety and performance requirements following reprocessing. This requirement is a matter of principle, not just an administrative burden.

Dear European Commission, We are a medical device manufacturer and would like to propose two measures to reduce unnecessary administrative burden under Regulation (EU) 2017/745 without weakening patient safety. Our EU MDR certificate was issued in May 2021.

BEUC welcomes the opportunity to comment on the revision of the EU framework for medical devices and IVDs. This revision provides an opportunity to strengthen shortage prevention, coordination, and transparency in a sector that directly affects consumers health and daily lives. However, several elements of the European Commissions proposal risk weakening hardwon patient safety gains and should be reconsidered.

The Horizon Europe Joint Undertaking Innovative Health Initiative (IHI) project, A Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) (https://heuefs.eu/), welcomes the publication of the proposed revisions to the Medical Device Regulation (MDR).

We strongly welcome the proposed amendment of Article 5(5) of the IVDR. The revision represents a pragmatic and balanced approach that strengthens patient access to high-quality diagnostic services while maintaining appropriate safeguards for safety, quality, and performance.

HOPE welcomes the proposed revision that aims to simplify the EU regulatory framework, reduce unnecessary administrative burden and support timely access to products. However, those efforts should not weaken the patient protection. The proposed revision of the Medical Devices Regulation (MDR) concerning artificial intelligence in Recital 23 and in article 4 of should be deleted.

The Austrian Society for Biomedical Engineering (OeGBMT) welcomes the European Commissions proposal to simplify the regulatory framework for medical devices and in vitro diagnostics, recognizing the need to reduce administrative burden while maintaining the highest standards of patient safety.

BSI welcomes the Commissions efforts to improve the efficiency and predictability of the MDR and IVDR, particularly through measures supporting breakthrough and orphan devices, digitalisation, and enhanced regulatory cooperation.

Revision of Regulation (EU) 2017/745 Electronic Instructions for Use (eIFU) for Medical Devices Intended for Lay Users EUROM 1 Optical Industries supports amending Regulation (EU) 2017/745 (MDR) to allow manufacturers to provide electronic Instructions for Use (eIFU) for medical devices intended for patients and other lay users.

AstraZeneca commends the European Commission for adapting the diagnostic regulatory framework to keep pace with technological advances and an expanding evidence base, enabling more timely access to high-quality diagnostics.

The European Social Insurance Platform (ESIP) acknowledges the objectives of revising the EU regulatory framework for medical devices and in-vitro diagnostics, reducing unnecessary administrative burdens and supporting timely access to medical technologies.

The College of Medical Immunologists in the Netherlands welcomes the proposed amendments to the IVDR and fully endorses their inclusion in the revised regulatory framework. Immunological diagnostics is a rapidly developing discipline, and the medical immunologists we represent rely on continuous innovation to deliver high-quality patient care.

The International Association of Mutual Benefit Societies (AIM), representing not-for-profit health insurance funds and health mutuals in Europe, Africa and Middle East as well as Latin America, regard the newly Commission proposal on simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, COM(2025) 1023, as a step in the right direction.

KU Leuven Research & Development (LRD), the Technology Transfer Office (TTO) of KU Leuven, submits this feedback on the proposed targeted revision of the MDR and IVDR from the perspective of an academic institution operating at the interface between research and MedTech commercialisation.

KARL STORZ SE & Co. KG welcomes the European Commissions targeted MDR revision and supports a more proportionate, efficient and innovation-friendly framework while maintaining high patient safety standards. Positive elements include Well-Established Technologies (WET), broader acceptance of non-clinical evidence, greater recognition of equivalence and selected simplification measures.

On behalf of Viroscience diagnostic laboratory at the Erasmus MC, Rotterdam, we welcome the proposed amendments to the In Vitro Diagnostic Medical Devices Regulation (IVDR) and strongly support their incorporation into the revised regulatory framework. The proposed changes will improve the flexibility, sustainability, and resilience of diagnostic services across the European Union.

Medical instruments should be designed as giants. If the manufacturer does not have a reusable variant, it shall be possible to clean it and reuse it. And if this cannot be done safely, an expert must be able to refurbishen them. This expert then becomes a manufacturer and provides a guarantee. Geopolitical circumstances no longer allow us to burn everything after 1x.

Filed in Dutch · English published by the European Commission

On behalf of the medical microbiology diagnostic laboratory in the LUMC, we welcome the proposed amendments to the IVDR and strongly support their incorporation into the revised regulatory framework. The proposed changes will improve the flexibility, sustainability, and resilience of diagnostic services across the European Union.

Roche welcomes and fully supports the European Commission's efforts to simplify and improve the EU rules for medical devices and in vitro diagnostics. We appreciate the opportunity to comment. Our comments on the revision proposal highlights changes that are particularly welcome and those needing clarification to address challenges and to safeguard patient safety and access to innovation. Feedback attached.

I very much welcome the European Commission’s call to contribute to the targeted revision of the EU rules on medical devices and in vitro diagnostics. The simplification of the regulatory framework and the reduction of administrative burdens is not only a strategic necessity for the competitiveness of the sector, but a vital duty towards the health of citizens.

Filed in Italian · English published by the European Commission

The current requirements of Article 5(5) IVDR impose substantial administrative burdens on health institutions that develop and use in-house IVDs for patient care, particularly in specialized and innovative diagnostic settings.

The Austrian Society of Medical Physics (OeGMP) is a professional society representing medical physicist working in the field of radiation oncology, radiology, nuclear medicine and audiology. We herewith submit our comments to the proposed changes of EU regulation 2017/746 (see attachment).

EFPIA fully supports the aim of the targeted revision for the MDR/IVDR to simplify and streamline the current regulatory framework. However, the proposal misses the opportunity to enhance the current system even further. On the governance process, EFPIA supports a greater coordination role taken by the EMA as well as expansion of expert panels remits.

The Council of European Dentists (CED), representing over 350,000 dentists across Europe, welcomes the Commissions proposal to amend the Medical Devices Regulation. In particular, the CED supports the elimination of the five-year validity period for certificates, viewing it as a significant step toward reducing the administrative burden on manufacturers.

Medicines for Europe welcomes the European Commissions proposal regarding the adoption of the MDR. We support the overall aim of making the regulatory framework simpler, more efficient and more proportionate, while continuing to ensure a high level of patient safety.

Bayer welcomes and fully supports the European Commission's efforts to simplify and improve the EU rules for medical devices and in vitro diagnostics. We are pleased to provide feedback on the proposal for a regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). Our feedback includes identified issues and proposed solutions. Please find our feedback attached.

EUCOPE welcomes the European Commission's targeted revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), recognising it as a timely opportunity to improve predictability, reduce unnecessary regulatory burdens, and strengthen Europe's competitiveness.

The targeted revision of the EU Medical Devices Regulation (MDR) is a crucial opportunity to make the European regulatory framework for medical devices more innovation-friendly, efficient and workable again, without compromising the high level of patient safety.

Filed in German · English published by the European Commission

Dear Sir or Madam, The European University Hospitals Alliance (EUHA), representing leading university hospitals across Europe, welcomes the European Commissions efforts to refine the regulatory framework under the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). EUHA member hospitals are firmly committed to quality, patient safety and regulatory compliance.

AmCham Slovakia welcomes the objective of making the system more proportionate, predictable and efficient while maintaining a high level of patient safety. What is needed now is a swift and balanced adoption of the proposal to address these shortcomings without further delaying patient access to safe and innovative technologies.

Following the submission of FEPPD's response to the European Commission's public consultation on the targeted revision of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), further discussions within the FEPPD network have identified an additional issue which, in our view, deserves consideration during the legislative process.

EDANA, the international association representing nonwovens industry, which includes the producers of critical protective, medical and hygiene products, would like to thank the Commission for the opportunity to provide input to the revised MDR.

We welcome the European Commissions initiative to revise the rules for medical devices and in vitro diagnostics. 1. The current proposal for revisions to the MDR/IVDR includes important amendments regarding in-house devices (Art. 5(5)). We strongly support that these revisions should be treated as high priority for adoption.

We welcome the Commissions target amendments to improve the functioning of the MDR and IVDR. By tackling structural issues, such as delays at notified bodies, unpredictable timelines and disproportionate administrative burdens and costs, the proposal strengthens regulatory stability, supports SMEs, and helps safeguard patient access to essential existing and innovative technologies.

The European Commissions targeted revision of the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) makes progress in addressing longstanding industry concerns through streamlined processes, dedicated pathways for innovations, broader acceptance of non-clinical evidence, regulatory harmonisation, greater clarity for innovative treatments and reducing duplication with…

It is important that the safety of the products used is a priority for the patient. However, the measures should be proportionate. The profit to be made must be compared with the investment in time, manpower and money. This is off balance sheet. We can only spend our money 1 times.

Filed in Dutch · English published by the European Commission

Mölnlycke welcomes the proposed revision to the Medical Device Regulation (MDR), as it represents an important step toward improving regulatory efficiency. The company supports the need to accelerate the application of these changes and avoid extending implementation timelines to three to five years.

From the perspective of public health laboratories, the proposed revision of the IVDR represents a significant step towards a more proportionate and practical regulatory framework. The proposal maintains the high level of patient safety established by the IVDR while removing administrative barriers that have unnecessarily complicated the development and implementation of innovative and highly specialised diagnostic…

In general, the simplification where it really improves efficiency has our support. However, it should not reduce the level of regulatory oversight to the point that predictability, harmonisation and patient safety are weakened. In our view, several proposed amendments, shifts the system from proactive and preventive oversight to a reactive system.

UL Solutions, a global leader in applied safety science, welcomes the European Commission's intent to simplify the medical technology system through the revision of the EU MDR/IVDR. UL Solutions supports the European Commission's further intention to keep Notified Body oversight strong. We would like, however, to highlight some concerns regarding the proposed governance of Notified Bodies.

The Medical University of Vienna welcomes the European Commissions initiative to reduce unnecessary regulatory complexity and to improve the efficiency of the medical device regulatory framework while maintaining a high level of patient safety.

On behalf of the Dutch Society for Medical Physics (Nederlandse Vereniging voor Klinische Fysica, NVKF), we would like to provide our input on the targeted revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Our members, Medical Physics Experts (MPEs) in Dutch hospitals, are responsible for the appropriate deployment, safe use, and availability of medical technology.

J&J welcomes the MDR and IVDR revision proposal as a long awaited and targeted response to concerns raised by a broad range of stakeholders, including patients, healthcare providers, Notified Bodies and the MedTech industry. The proposed revision is an important contribution to Europes broader competitiveness and innovation agenda.

The European Society for Medical Oncology (ESMO) - a professional society representing over 50,000 members globally - welcomes the European Commissions proposal for a targeted revision of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Essity is a leading global hygiene and health company touching the lives of 1 billion people every day. Europe is one of our primary markets for developing, producing, and distributing our products such as tissue paper products, absorbent hygiene products e.g. incontinence products, menstrual products, baby diapers as well as wound care products and other medical solutions.

We thank the Commission for the possibility to provide feedback on the targeted revision of the MDR/IVDR. We fully support the initiative to streamline and simplify the regulatory framework while preserving a high level of public health and patient safety. Please find our comments in the attached file.

The Diagnostic Clinic at Innlandet Hospital Trust supports the Commissions proposal to revise the IVDR. As stated in the revision proposal, IVDR in its current form poses several challenges for health institutions, particularly with regard to the in-house exception (Article 5.5).

It is importent for health institutions nearby to be able to use the main hospital's inhouse IVDR equipment, to avoid errors and extra burden for patients. There is often cooperation between these hospitals, and pasient samples are sent to futher investigation at the main hospital. Especially important for class D IVDR equipment!

FEPPD respectfully submits the attached position paper in response to the European Commission's public consultation on the targeted revision of Regulations (EU) 2017/745 and 2017/746. The attached document contains FEPPD's detailed observations and recommendations, based on the practical experience of European dental laboratories manufacturing custom-made medical devices.

Healthtech Finland thanks the Commission for the possibility to give feedback on the proposal for the amendment of the medical device regulations (MDR and IVDR). The MDR and IVDR change proposal addresses many of the pressing questions and challenges the healthcare sector, healthcare organisations and professionals, as well as the medical device industry, are currently experiencing.

SIDIV is the national association in France which units and represents companies in the IVD sector (around 80 companies, from start-up and SMEs up to multinationals). SIDIV welcomes and strongly supports the European Commission s proposal to revise the IVDR and urges the European Parliament and the Council to deliver an improved system swiftly.

We welcome the European Commissions targeted revision of the In Vitro Diagnostic Regulation (IVDR) and support its objective of ensuring high patient safety and quality in diagnostics. From the perspective of a hospital laboratory within the public healthcare system, we consider it essential that the revision of Article 5(5) on in house in vitro diagnostic devices (IH IVDs) better reflects and supports the framework…

The European Association for Nuclear Medicine (EANM) welcomes the European Commissions proposal for a revision of the Medical Device Regulation (MDR). The MDR has been crucial for healthcare professionals (HCPs), including for the nuclear medicine community, as it establishes a robust framework to ensure the safety, quality, and performance of medical devices used in diagnostics and therapy.

We welcome the European Commissions initiative to revise the regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) and appreciate the opportunity to contribute to this consultation and support efforts to maintain a regulatory system that ensures patient safety while providing the flexibility necessary to support preparedness and responsiveness of health systems in the EU.

Please find attached UZ Leuvens feedback letter concerning the proposed adaptation of the EU rules for medical devices and in vitro diagnostic medical devices. We appreciate the opportunity to contribute to this consultation and remain available for further dialogue. The letter addresses the following topics: 1. Feedback supporting the proposed amendment of IVDR/MDR Art.

Dear Sir or Madam, The European University Hospitals Alliance (EUHA), representing leading university hospitals across Europe, welcomes the European Commissions efforts to refine the regulatory framework under the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). EUHA member hospitals are firmly committed to quality, patient safety and regulatory compliance.

As leading Medtech companies in Europe, Ambu, Coloplast, Mölnlycke, and Solventum support the response submitted by Swedish Medtech to the Commissions consultation on the revision of the MDR, and are hereby submitting our joint statement to further highlight key issues and recommendations.

The Verband der Diagnostica-Industrie e.V. (VDGH) welcomes the December 2025 European Commission proposal for a targeted revision of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The draft includes essential and urgent measures to simplify regulatory procedures, reduce unnecessary administrative burdens and strengthen the long-term stability of the European diagnostic market, without…

Filed in German · English published by the European Commission

Executive summary - ESHG key positions The ESHG strongly endorses the Commissions proposed amendments to Article 5.5 of the IVDR and respectfully requests that the final text incorporate the following five evidence-based positions: (i) complete deletion -not amendment - of the equivalence-justification requirement in Article 5.5(d); (ii) explicit authorisation of inter-institutional transfers of in-house IVDs…

A targeted revision of MDR and IVDR is necessary to restore predictability, protect patient safety, and safeguard access to the health technologies that citizens rely on. Without improvements to how the framework operates in practice, delays, uncertainty and disproportionate requirements risk limiting availability of existing technologies and slowing access to new innovation.

The main objective of the proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 is to simplify the applicable rules and to reduce the administrative burden on manufacturers. However, the proposed revised rule 11 does not achieve a simplification of the existing rule.

DNV's full contribution is attached, and summarized hereafter. DNV welcomes the European Commissions effort to revisit Regulation (EU) 2017/745 (MDR) in order to improve implementation, reduce avoidable burden and support timely access to safe and effective medical devices and in vitro diagnostics in the European Union.

IDF Europe represents 72 national diabetes associations across 45 countries in the European Region. IDF Europe acknowledges the importance of the Medical Devices Regulation in ensuring the quality, safety and performance of medical devices that are placed on the EU market.

The European Hematology Association (EHA) welcomes the proposed targeted revision of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and supports measures to improve regulatory proportionality, reduce unnecessary bureaucracy, and safeguard patient access to essential diagnostics while maintaining high standards of safety and performance.

The European Society for Magnetic Resonance in Medicine and Biology (ESMRMB) is an international and interdisciplinary scientific society promoting the development and application of magnetic resonance imaging (MRI) in Europe. MRI is indispensable in medical diagnostics and widely recognized as a safe modality, particularly as it does not involve ionizing radiation.

MedTech Europe welcomes the opportunity to provide feedback to the European Commissions proposal around the targeted reform of EU rules on medical devices (MD) and in vitro diagnostic medical devices (IVD). Europes regulatory framework for medical technologies is at a decisive moment.

The evaluation of the MDR identified several structural shortcomings affecting the efficiency, predictability, and proportionality of the system, with direct consequences for innovation, device availability, healthcare delivery, and patient access across the Union.

We strongly support the Targeted Revision of Regulation (EU) 2017/745 (MDR) and urge its swift adoption. The revision is a necessary and urgently needed corrective measure. With the long time of certification assessments, there would be a critical certification bottleneck from 2027, delays in enacting these reforms risk to face again the lack of MDR devices in the market with jeopardising patient access to safe and…

The Single Market plays an important role in supporting access to affordable medical devices across the EU. By enabling their redistribution between Member States, from markets where there is a surplus to others where there is a need, it contributes to improved availability, a more efficient allocation of medical devices, and greater affordability through enhanced competition.

Comments to MDR/IVDR Proposal By SGS Belgium NV (NB1639) Non-exhaustive lists With the understanding of the EU regulatory objective of ensuring that only safe and effective medical devices reach the market must be maintained, I consider that the proposed amendments risk undermining this goal rather than simplifying the system.

As manufacturer of in vitro diagnostic devices, we recognise the significant progress contained in the Commissions proposal, particularly regarding innovation pathways, administrative simplification, and strengthened international cooperation. At the same time, several provisions on regulatorystatus governance, scrutiny mechanisms, and the expanded role foreseen for EMA require substantial revision.

Confindustria Dispositivi Medici is the Italian trade association representing companies in the medical device and in vitro diagnostic sector. We share the priorities of the European medical technology sector in promoting innovation, patient safety, and a competitive regulatory environment.

We fully support the Team NB position on the proposed MDR and IVDR revisions, which provides comprehensive analysis of the key issues. As a mid-size Notified Body, we highlight additional critical concerns: 1. Fee structure unsustainability: Mandating up to 50% fee reductions for SMEs is commercially unviable, compounded by EU Commission authority to set fee caps.

Please find attached Swedish Medtechs consultation response regarding the European Commission’s revision proposal of the MDR and IVDR, in Swedish. Swedish Medtech is the industry association for manufacturers and suppliers of medical devices in Sweden.

Filed in Swedish · English published by the European Commission

KBV considers the proposed changes to be acceptable, provided that they help to make regulatory procedures more reliable and straightforward and ensure the availability of medical devices on the European market. At the same time, KBV emphasizes that patient safety and the functionality of medical devices remain of paramount importance.

Thank you for the possibility of commenting the Proposal for amendment of MDR and IVDR. We understand the complexities that small medical device and IV device manufacturers are facing in meeting the reguirements of the Regulations.

Members of EAAR act as independent Authorised Representatives on behalf of thousands of non-EU manufacturers. EAAR believes that the additional flexibility introduced by the proposed change to Article 11 is positive and provides new efficient options for the manufacturers.

EHIMA welcomes the European Commissions targeted MDR revision and appreciates the opportunity to contribute to this important consultation. EHIMA supports the Commissions efforts to strengthen efficiency, proportionality and legal certainty while maintaining high patient safety standards. The input focuses on reducing fragmentation, improving predictability, and ensuring balanced AI and cybersecurity requirements.

1. General remarks The Department of Microbiology and Infection Control at the University Hospital of North Norway welcomes the European Commissions initiative to revise the regulatory framework for medical devices and in vitro diagnostics.

As a service provider for innovation-supporting measures under the Medical Technology Programme of the German Federal Ministry of Research, Technology & Space (BMFTR), we highly welcome the COM proposal to reform MDR and IVDR. Generating clinical evidence through clinical investigations for medical devices is key, but costly.

Pharma Deutschland welcomes the European Commissions initiative to simplify the EU regulatory framework for medical devices and to enhance the competitiveness of the European medical device sector within the internal market and at global level.

It's appreciated that MDR is under review,even though the changes will probably produce additional 5 years of confusion in sector. Below some points not addressed by the changes,that I suggest to clarify: PRRC: still unclear if the PRRC has legal responsibilities like QP in pharma (in Italy PRRC could be fined over than 100k) even though the wording of MDR and Drug Directive is different.

Support for shifting MDR and IVDR to Annex I, Section B of the AI Act: Bitkom supports the proposed transfer, as it can reduce duplicative regulation and avoid unnecessary double burden for AI-based medical devices.

Art. 82 MDR Handling of other clinical investigations As a service provider for innovation-supporting measures under the Medical Technology Programme of the German Federal Ministry of Research, Technology and Space (BMFTR), we welcome the COM proposal to reform the MDR and IVDR. The Commission proposes the complete removal of Article 82 MDR on other clinical investigations.

Feedback on the targeted revision of Regulation (EU) 2017/746 (IVDR) We welcome the opportunity to comment on the targeted revision of Regulation (EU) 2017/746 (IVDR). This response is submitted from a hospital-based department of medical microbiology that provides diagnostics for patient care, infection control, outbreak management and public health.

Clinical evaluation with proportionate risk assessment - In Expert Opinion CECP-2022-000232, one recommendation was to conduct an evaluation of all implants and combinaisons of a complex orthopaedic joint replacement system. It should be understood that all implant versions for all intended combinaisons in all claimed indications must have specific clinical data.

AESGP, the Association of the European Self-Care Industry, generally welcomes the European Commissions legislative proposal on simplifying and reducing the burden of the rules on medical devices aiming to improve the functioning of the current regulatory framework, notably regarding the smooth functioning of the single market for medical devices, while ensuring a high level of health protection for patients and…

Article 15 about the Person Responsible for Regulatory Compliance (PRRC) does not specify what the PRRC should, how, and who they should report to. This results in confusion and in my daily work I see PRRCs struggling with with lack of clarity. This often does not have a positive effect on the safety of medical devices. Attached is my take on Article 15.

The current EU medical device framework is crushing small and micro manufacturers. In our experience, the process is so slow, so expensive, and so unpredictable that it is actively driving smaller companies away from the EU market. At this point, the burden is not just excessive, it is unreasonable. Our company spent more than three years trying to obtain certification.

Notified Bodies Coordination Group for Medical Devices (NBCG-Med) welcomes European Commissions initiative to address identified challenges in the implementation of Regulations (EU) 2017/745 and 2017/746 (MDR/IVDR) through a targeted revision.

We appreciate the opportunity to comment on the Commissions proposal to amend Regulation (EU) 2017/746 and welcome the initiative to simplify the regulatory framework and reduce unnecessary administrative burden.

This has been a horrible process to go through to obtain MDR. It took almost two years to get our technical files audited. With the points following being the most difficult to deal with when our products our low risk.

I am submitting this white paper to this initiative because it is closely related to the issues addressed in our study on the launch and internationalisation of new products in the life sciences industry, especially for small and medium-sized enterprises (SMEs).

NITO The Norwegian Institute of Biomedical Science (NITO BFI) welcomes the European Commissions proposal to revise the IVDR with the aim of simplifying procedures, strengthening supply security and maintaining a high level of patient safety.

Dear Mr/Mrs, On 10 April a position statement of the Euroepan Federation of Laboratory Medicine (EFLM) was uploaded. So far its committee on European Regulatory Affairs (EFLM C-ERA) has been working on an ANNEX with essential in-house developed tests that illustrate why medical laboratory professionals absolutely need the revised and flexibilized Art 5.5 as described in the reformed IVDR proposal d.d.

Attached MedTech Denmarks (Medicoindustrien) consultation response regarding the European Commissions revision proposal of the MDR and IVDR. MedTech Denmark is the industry association for manufacturers and suppliers of medical devices in Denmark and has prepared the attached material through close engagement with its members.

Haukeland University Hospital's Department of Laboratory Medicine and Pathology, serving a catchment population of 1.1 million inhabitants in Western Norway, strongly supports the proposed deletion of IVDR Article 5(5)(d), alongside the amendments to Articles 5(5)(a), 5(5)(f), and 5(5)(g), as these changes collectively preserve critical flexibility for clinically necessary in-house testing while alleviating…

My feedback as a Medical Device Consultant who has specialized in achieving EU MDR CE certification under the MDR 2017/745: This has been a significant hardship for all medical device manufacturers and the costs under MDR are 4 - 5X the prior cost assessed by ALL Notified Bodies.

Dear Mr, Mrs, On behalf of the European Federation of Laboratory Medicine (EFLM) I like to bring EFLMs position statement on proposal COM(2025)1023 - 2025/0404(COD) under your attention. EFLM and its members are EU-wide responsible for 24/7 hour laboratory diagnostics, 365 days a year. Medical decisions for patients depend for 70% on lab test results that diagnostic labs produce.

Eurofins E&E notified bodies (Finland and Italy) and Eurofins E&E candidate in the process of the designation (France) would like to provide feedback on the proposed amendments of the EU Medical Device Regulations.

Feedback on COM(2025)1023 Targeted revision of MDR/IVDR Submitted by: QuaSer S.r.l. Regulatory Affairs Consultancy, Rome, Italy Perspective: SME regulatory consultancy with over 30 years of experience in EU medical device regulation, acting as PRRC (Art. 15 MDR) for multiple Italian manufacturers We welcome the Commission's initiative to revise the MDR and IVDR.

Labcorp is a global leader in innovative laboratory services and the market leader in central laboratory services (CLS) supporting EU-based clinical trials through t testing samples from EU patients. Biotech and pharma rely on CLS to provide the highest level of global data consistency, crucial to multinational clinical trials Labcorp welcomes the Commissions proposal to streamline and simplify the MDR and IVDR…

On 16 December 2025, the European Commission presented its proposal for an amendment to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). With the amendments, the European Commission aims to simplify the MDR and IVDR and make them simpler, faster and more effective, while maintaining high safety standards.

Filed in German · English published by the European Commission

Team NB, the European Association of Medical Devices Notified Bodies, welcomes the opportunity to provide comments on the draft revision of EU Regulations. We support the Regulations objective of ensuring that only safe and effective devices are placed on the EU market, thereby safeguarding safety and public health while fostering innovation.

Eurocom expressly welcomes the proposal of the revised MDR. In particular, eurocom highlights the timely submission of the proposal, which required a considerable amount of work from the European Commission, Directorate-General SANTE, within a short timeframe. At the same time, early completion is necessary to ensure that the new regulations come into force in a reasonably timely manner.

Leaseuropes earlier Feedback in response to Call for Evidence highlighted the need for clarification that independent leasing companies should not qualify as distributors under the MDR. Whether this is achieved through a change to the Regulation, or through supporting guidance from the Commission, it remains important that ongoing confusion in the market over this point is resolved to support essential choice and…

Health Italia S.p.A. welcomes the European Commission’s initiative aimed at the targeted revision of the MDR and IVDR Regulations. We believe that a simpler, more proportionate and predictable regulatory framework is essential to ensure timely access to safe and innovative health technologies for European citizens.

Filed in Italian · English published by the European Commission

The targeted evaluation and revision of the Medical Device regulation have several positive incitements to stimulate both innovation as well as safe implants available for our patients. EFORT welcomes some improvements (further details in the file below).

Please review article 22 and the definition of a system, as the applicability of this article is currently being misused by Notified Bodies. The burden that comes with such definition is unfortunatly NOT limited to documentation, such as the declaration, but come with a real significant extra financial burden for SMEs, who already have regulatory challenges to overcome.

With respect to the proposed amendments in IVDR Article 5(5)(a), allowing health institutions to transfer in house manufactured blood bank test cells for blood typing and antibody screening, when justified by patient safety or public health, constitutes an important and well founded proposal.

The TÜV Association welcomes the European Commission's initiative to revise Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The implementation of both regulations led to a multitude of issues and open questions in the past.

Proposed amendment to the draft revised Article 17 MDR: As part of the public consultation on the targeted revision of the EU regulatory framework for medical devices, we would like to submit the following proposal for an additional paragraph to the draft revised Article 17 MDR.

novineon CRO GmbH, Germany, welcomes the Commissions efforts for amending MDR. At novineon, clinical evaluations are a primary area of expertise. Therefore, we would like to submit suggestions for further amending Art. 61: Issue Statement Current/proposed MDR wording require level of clinical evidence provided in clinical evaluations to be appropriate in view of characteristics/intended purpose of the device.

EHN welcomes the overarching objective of the proposed MDR revision to accelerate patient access to safe and effective medical devices, while reducing unnecessary administrative burden. Timely access to innovation, continued availability of essential technologies, and a stronger patient-centred approach are particularly important for people living with cardiovascular disease, which remains the leading cause of…

Expert opinion on the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 Berlin, 13 February 2025 · The AWMF (Association of the Scientific Medical Societies in Germany) comments on the Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices.

The center for laboratory medicine at Østfold Hospital welcome the Commissions proposal to revise the EU rules for medical devices and in vitro diagnostics. The commission highlights many of the current pain points that public hospitals experience with the current regulatory body, both directly and indirectly.

The citizens’ association ‘Electrosmog and Health’ welcomes the aim of ensuring a high level of patient safety. The inclusion of protective devices intended to reduce exposure to electromagnetic fields among medical devices or their accessories should also be considered in the upcoming revision of the rules on medical devices.

Filed in Slovak · English published by the European Commission

MDR, Annex XIV, list of clinical evaluation activities The current wording does not reflect the actual logic of the clinical evaluation process and may therefore create confusion and inconsistent interpretation. First, the listed items are presented as a linear sequence, although in practice the clinical evaluation is not carried out in that order.

MDR, Annex XIV, last bullet in bullet list The current wording, and a PMCF, lacks clarity and may give rise to interpretative uncertainty. The use of the indefinite article suggests that the provision refers to one specific PMCF activity or measure, but the text does not identify which activity is intended.

MDR, Annex XIV, bullet list New bullet point on benefit-risk issues is not clear and easy to understand because "benefit-risk issues" are undefined. Proposal to improve the sentence to make it easier to understand: An indication of how component-specific benefit-risk considerations, including those arising from the use of pharmaceutical substances, non-viable substances of human origin, or non-viable animal tissues…

MDR, Annex XIV bullet list. Improve wording of "indicative list" to avoid confusion. The current wording is one of the sources of misunderstandings and most often deficiencies, creating a chicken-egg loop for manufacturers, leading to the CEPs that require the assessment of state of the art before the plan is done.

Revitalised Medicine supports the Commission for its development of expert panels and regulation that promotes specialised, advanced, and ethical medical device use through the revision of rules regarding medical devices and in vitro diagnostics.

We thank you for launching the consultation on the targeted revision of the EU legislation on medical devices and in vitro diagnostic medical devices and would like to provide the following feedback on behalf of the Austrian Ministry of Labour, Social Affairs, Health, Care and Consumer Protection .

EIGA propose the following areas for the final version of the MDR: We support the creation of expert panels to provide timely guidance in case of divergent interpretation on classification by Notified Bodies and ensure regulatory consistency in interpretation of regulatory requirements.

MDR Feedback, from the coalition of Dutch university medical centers. We support the Commissions goal to simplify the MDR/IVDR framework, but several elements of the current proposal risk increasing administrative burden for academic clinical research, particularly due to the deletion of Article 82 MDR. 1.

Regarding Rule 11. As a manufacturer of an electronic health record (EHR) system, we wish to comment on the proposed Rule 11 and its implications particularly for EHR software. The current Rule 11 is widely criticized for its binary logic, which effectively classifies software as at least Class IIa if it qualifies as a medical device.

Feedback on Proposal COM (2025) 1023 Amendment of Article 18(3) EU MDR We refer to the proposed Amendment COM (2025) 1023, under which Article 18(3) of Regulation (EU) 2017/745 would be revised so that the current list of specifically exempted devices is replaced with an exemption covering well-established technology devices.

The Ad Hoc Committee on Medical Devices of the Association of the Scientific Medical Societies in Germany (AWMF) is a committee of the umbrella organization of the German scientific medical societies. It addresses issues related to medical devices and therefore also this evaluation, which explicitly does not refer to in vitro diagnostics.

The Medical Device Manufacturers Association -MDMA (a US-based trade association that represents hundreds of innovative medtech companies) supports the EU Commissions efforts to streamline, simplify and reduce the time and cost for bringing safe and effective MDR and IVDR medical innovations to hospitals, doctors and patients across the EU. This is both a critical and noble goal.

1 Proposal to amend Article 7.8 of Annex VIII to the MDR: We consider it unjustified to tighten up the regulation contained in the Commission’s proposal, which today exempts GIs that are locally dispersed on the human body from classification under Rule 21. The proposed tightening is not justified anywhere, we see no reason for it and, overall, we consider it inconsistent with efforts to simplify the process.

Filed in Czech · English published by the European Commission

Subject: Disproportionate and non-harmonised reprocessing validation requirements under Regulation (EU) 2017/745 As a European manufacturer of reusable medical devices, we are currently facing major difficulties resulting from the disproportionate and inconsistent interpretation of reprocessing validation requirements under Regulation (EU) 2017/745.

The Division of Laboratory Medicine at Oslo University Hospital, the largest clinical laboratory division in Norway, supports the Commissions proposal to revise the IVDR. As stated in the revision proposal, there are several weaknesses in the present IVDR. We welcome the proposed revisions, especially those related to in-house devices in IVDR Article 5(5).

The proposed relaxations within the IVDR legislation can have a positive impact on the development, implementation and application of LDTs within diagnostics. The increased flexibility and simplified procedures contribute to a more efficient use of clinical trials, which can ultimately lead to better patient care and innovation in medical diagnostics. 1.

Filed in Dutch · English published by the European Commission

The proposed measures to simplify the MDR are, in principle, welcome, particularly where they aim to improve efficiency and reduce unnecessary administrative burden. However, their implementation raises significant concerns regarding fairness and competitive balance between manufacturers.

The EU understands that there is a massive problem with the way the MDR has been set up. This is in itself a great progress. However, the root cause of the problem is that the concept of a Notified Body is inherently flawed. It's a private company that wants to maximise profits, which is normal.

Dear Sir or Madam, I am submitting this feedback as an independent expert in digital health and MedTech innovation. I strongly support the Commissions initiative for a targeted revision of the MDR/IVDR to reduce administrative burdens and foster innovation.

As in previous rounds of consultations, the Bavarian State Ministry for the Environment and Consumer Protection welcomes the revision of the EU Regulations on medical devices and in vitro diagnostic medical devices. Many of the known solutions proposed by Bavaria have been implemented by means of this proposal for a Regulation. In our view, however, the requirements for classifying software are not sufficient.

Filed in German · English published by the European Commission

We are welcoming most of the changes, but it is most important that the changes that open up for different sources for clinical evidences in MDR, also will be implemented in IVDR. Removing the requirement for reassessment every 5 years was very important.

Has the EU Medical Device Regulation (MDR) improved patient safety? We beleive that its current implementation creates excessive legal, administrative, and financial burdens that hinder innovation and disproportionately affect SMEs and micro-enterprises. Manufacturers face overly demanding clinical and post-market data requirements even for long-established, low-risk devices.

We welcome the hearing on the IVDR-regulation! Our primary focus relates to in-house issues. In our view, it is crucial that the regulation allows a certain degree of flexibility, especially since laboratories are not manufacturers, but providers of diagnostic services. We support simplified regulation for in-house devices. a) We support the suggested text. b) Keep!

Thank you for your work in favor of the medical device sector and, ultimately, public health. I am generally in agreement with the Commission's proposal of December 16, 2026. This proposed text significantly simplifies the current MDR and IVDR texts. The financial burden imposed by regulatory procedures will be significantly reduced if the final text voted on by Parliament is close to the Commission's proposal.

We strongly welcome the European Commissions initiative to carry out a targeted revision of the MDR and IVDR. From the perspective of a small and medium-sized enterprise (SME) operating in the IVD sector, the proposal sends an important signal that existing implementation challenges have been recognised and that structural improvements are being pursued.

Dear Commissioner Varhelyi, As a German manufacturer of software as a medical device (SaMD), we expressly support the objective of the European Commission to reclassify devices in a way that saves time and effort and is more proportionate to their inherent risk.

We, Europeans for Safe Connections (ESC), have the following comments to the document Evaluation and the Regulation : The Evaluation document does not explicitly mention electromagnetic fields (EMF) or the condition of electromagnetic hypersensitivity (EHS). The Commissions text focuses almost exclusively on: Administrative burdens and procedural complexity.

This has already been raised by another contributor, but there seems to be an error in the revised Rule 11 whereby it is stated : Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease…

We welcome the Commissions initiative to revise the EU rules for medical devices and in vitro diagnostics. The current proposal for revisions to the MDR/IVDR includes important amendments regarding in-house devices (Art. 5(5)). We strongly support that these revisions should be treated as a high priority for adoption.

Fairpharm appreciates the opportunity to comment on the Commissions proposal to amend Regulations (EU) 2017/745, 2017/746, 2022/123, and 2024/1689. We welcome the initiative to simplify the regulatory framework and reduce unnecessary administrative burden.

As an argument, product safety should be at the top. This does not mean, however, checking once a year according to the file in the QM Manual. The test should be carried out by sampling the product on the market and appropriate testing in a laboratory or a TÜV.

Filed in German · English published by the European Commission

Subject: Leveraging computer modelling and simulation methodologies including AI, to mitigate current challenges and prepare for future needs. The VPH Institute (VPHi), an international scientific society representing experts in in silico medicine (use of computer modelling and simulation in health and care) from academia, research institutes, hospitals, and health technology assessment bodies, supports the European…

As a European manufacturer operating globally, LINET welcomes the Commissions initiative to simplify and modernize the MDR framework. While the Regulation strengthened patient safety, it also generated significant legal and administrative complexity that hampers innovation, particularly for SMEs and digital-health manufacturers. 1.

Northern Ireland (NI), although a nation within the United Kingdom (UK), follows the EU MDR and IVDR. The rest of the UK, known as Great Britain (GB), follows the UK Medical Device Regulations. This has led to regulatory divergence across the UK and is ultimately the result of Brexit and the Northern Ireland Protocol signed and agreed by the UK and EU governments.

As a health professional and director of a Spanish biomedical company, I am grateful for the opportunity to provide data for the targeted review of EU rules on medical devices and in vitro diagnostics. In this way, I would like to make the following comments on some negative consequences that I think the new IVDR regulatory framework will have: 1.

Filed in Spanish · English published by the European Commission

As a research institution, we find it increasingly difficult to bridge the gap between research, industry and clinical application. In our field of research on AI-based surgical assistance systems, there are often still too many uncertainties in order for companies to take over the approval process, so we need to first validate our systems in a clinical setting by ourselves.

The MDR has strengthened patient safety and quality oversight, but the implementation of conformity assessments through Notified Bodies (NBs) has exposed structural inefficiencies that impede timely market access and innovation. The following concerns require attention in the targeted revision. 1.

While introduced to enhance patient safety and transparency, the EU's Medical Device Regulation (MDR) has created significant systemic and operational challenges that are undermining the European medical technology ecosystem. This report analyzes the cumulative impact of the regulation, revealing a framework struggling with infrastructural deficiencies, a lack of regulatory clarity, and legislative incoherence.

We welcome and support the European Commissions initiative to revise the MDR and IVDR regulations with the aim of simplifying and streamlining the framework, improving cost-effectiveness, and ensuring high standards of public health and patient safety. Additional Critical Points A.

We appreciate the opportunity to contribute to the ongoing dialogue around regulatory alignment and fully support the objective of ensuring the safety, quality, and effectiveness of diagnostic products used in routine clinical practice.

One of the challenges with the EU MDR is that it imposes very strict equivalence criteria, making it extremely difficult to leverage clinical data from existing products to support similar devices. This rigidity may result in having to collect high-ranking clinical evidence, even when safety and performance have already been well established.

The Association of Researching Pharmaceutical Manufacturers – vfa – welcomes the revision of the current EU rules on medical devices (MDR) and sees this as a clear opportunity to make the existing regulatory framework more realistic, less bureaucratic and more supply-oriented. Not least the reduction of bureaucratic and regulatory hurdles without added value should be part of the associated considerations.

Filed in German · English published by the European Commission

CZEDMA Position Paper on the Targeted Revision of the IVDR (Regulation (EU) 2017/746) About CZEDMA CZEDMA (Czech Association of Manufacturers and Suppliers of In Vitro Diagnostics) is a national association representing manufacturers, authorised representatives, importers, distributors and suppliers of IVD medical devices active on the Czech market.

NèreS is the French association representing pharmaceutical laboratories producing medicinal products, medical devices and food supplements; the Commission wishes to submit its contribution to the public consultation on the simplification of EU rules on medical devices and in vitro diagnostics.

Filed in French · English published by the European Commission

Critique and Recommendations on the EU Medical Device Regulation (MDR) The EU Medical Device Regulation (MDR) has undoubtedly strengthened patient safety, transparency, and post-market oversight within the European market.

Becton Dickinson and Company (BD) supports the European Commission's efforts to revise the IVDR and MDR. We appreciate this opportunity to contribute to the call for evidence and share our perspective on recalibrating these regulations to better serve patients, healthcare systems, and the medical technology sector.

Veeva Systems welcomes the opportunity to provide feedback on the targeted revision of EU rules for medical devices and in vitro diagnostics. Our response highlights the urgent need for a mandatory, structured electronic submission format to strengthen Europes data governance, enhance efficiency, and accelerate patient access to safe, innovative technologies.

The European Organisation for the Research and Treatment of Cancer (EORTC) supports the European Commissions initiative to simplify the EU rules for medical devices and to strengthen the competitiveness of the European medical device sector.

Call for Evidence MDR / IVDR: Comments from MDMA (Medical Device Manufacturers Association) based in Washington DC with regulatory advisor in Brussels. MDMA welcomes the opportunity to submit evidence. The new regulatory framework should address the problems with the current system, which especially impact SMEs, as follows: -There should be recognition of the predominance of SME participation in the medtech sector.

Summary of Porta Medicas Comments on the Revision of MDR and IVDR Porta Medica welcomes the European Commissions initiative to revise the MDR and IVDR and supports the objective of ensuring patient safety and high regulatory standards.

As health authorities we understand and share the course of action at European level to increase the competitiveness of our sector, simplifying legislative texts, increasing process agility and reducing possible administrative burdens. These European guidelines are aimed at promoting innovation in the medical device sector and ensuring our population’s early access to medical devices.

Filed in Spanish · English published by the European Commission

We appreciate the opportunity to contribute to the European Commissions targeted evaluation of the EU Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746). This initiative is critical to addressing structural challenges that have emerged since implementation and to ensuring that the regulatory framework continues to safeguard patient safety while supporting innovation…

Dedalus is a well-established European-based medical software manufacturer regulated under MDR and IVDR. Our portfolio spans primary care, hospital systems, diagnostics, emergency care, and population health management.

Medtronic welcomes the European Commission's initiative to implement the targeted review in 2025. While the Medical Device Regulation rules were aimed to improve safety, quality and transparency, they added costs and administrative burden that had slowed down innovation in the EU compared to other regions, risking delayed patient access to devices.

Thank you for giving us the opportunity to contribute to the targeted review of the MDR. The introduction of the MDR has greatly increased the costs of certifying and maintaining certificates, without providing more safety or performance for the patient. Some devices addressing a patient need have been stopped as a result of a higher cost of keeping on the market than the revenues generated.

Filed in French · English published by the European Commission

Medicines for Europe welcomes the opportunity to comment on the targeted revision of the EU rules for medical devices and in vitro diagnostics. We support a revision that makes the system clearer, more efficient and proportionate, as the current Medical Device Regulation (MDR) has created many challenges for products that combine a medicine and a device leading to delays, uncertainty and additional administrative…

Medical devices have become an essential component of diabetes management. Yet, despite their increasing availability, many of the 34 million people living with diabetes in the EU do not achieve their treatment targets. This highlights the need to foster more innovation and facilitate the introduction of new devices that better meet people's needs.

One devasting consequence of the new regulation is the withdraw of numerous implants while their risks are properly mitigated since decades. These increasing withdraws will generate future lack of therapeutic solutions, putting patients in danger where the EU new regulation was supposed to ensure patients safety Several reasons explain this fact.