Implementing rules regarding requirements to be met by notified bodies

LINET spol. s r.o. is a global manufacturer of medical devices supplying healthcare providers worldwide, including the EU. We welcome the European Commissions initiative to ensure a more uniform application of requirements for Notified Bodies (NBs) under MDR/IVDR and we support measures that improve predictability, transparency and comparability of conformity assessment processes and outcomes across the Union.

We appreciate the opportunity to respond to the public consultation on the draft of the Regulation. In Article 1 there is an obligation for NB to obtain the information if the manufacturer is an SME, but it does not follow with any difference in approach to the certification procedure.

PCBC, as a Notified Body, supports the need to streamline conformity assessment procedures, enhance predictability, and ensure timely access to the EU market for medical devices. However, the proposed amendments should not result in an increased administrative burden for Notified Bodies.

DNV Product Assurance welcomes the Commissions intention to improve predictability, transparency, and timeliness in conformity assessment. However, several proposed requirements would benefit from further refinement to prevent unintended consequences. We support the harmonized and pragmatic approach laid out by Team NB. Please find attached our additional feedback.

The proposal is intended to bring welcome predictability to the timelines of the MDR and IVDR certification. However, it appears that - there has been almost no impact assessment done to the effects of the proposal and - the scope of the proposal exceeds the legislative purpose that is intended for Implementing Acts.

As a consultant with many years of experience in the medical device industry, particularly for small and medium-sized manufacturers and start-ups, I consider the creation of detailed regulations for Notified Bodies to be essential and long overdue, especially those that lead to a better reliability for the time required for conformity assessment and the costs that have to be expected.

SIQ Ljubljana, notified body for medical devices and a member of Team NB, welcomes the opportunity to comment on the draft Implementing Regulation amending AnnexVII MDR/IVDR. We support the goal of improving predictability, consistency and transparency in conformity assessment, but several elements of the draft raise significant legal, proportionality and feasibility concerns.

The Czech Republic and ÚNMZ, in its capacity as the national authority responsible for notified bodies, takes note of the draft implementing acts as well as the draft regulation intended to simplify the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

GMED welcomes the intetnion of the implenting act proposal which aims at improving the predictability of certification cost and timelines. Tha said, GMED agrees with the concerns raised in the position paper of TeamNB. (attached). In addition GMED raises the following concern: With regard to SMEs, it is no the role of NBs to support SMEs ; that responsibility lies with the Member States.

The Association of Manufacturers and Suppliers of Medical Devices (AVDZP), representing the Czech MedTech industry across the full value chain, welcomes the European Commissions initiative on the uniform application of requirements for notified bodies (Implementing Regulation draft, Ares(2025)11081575). Please find attached AVDZPs feedback.

COMIDENT, representing the French dental industry, thanked the European Commission for this consultation. For manufacturers of medical devices (MDs), it is very important to have heard the major problems encountered in the application of Regulation (EU) 2017/745 (MDR). This applies in particular to your proposals for Notified Bodies (NoBs).

Filed in French · English published by the European Commission

DEKRA Certification BV supports the objective to enhance transparency, predictability, and efficiency of conformity assessment procedures under the MDR/ IVDR. Clearer expectations regarding quotations, timelines, and monitoring may contribute to a more robust regulatory framework and facilitate timely patient access to safe and innovative medical devices.

We would like to thank you for the opportunity to provide feedback. The draft text aims to harmonise quotation practices, timelines, and re-certification procedures among notified bodies (NBs). While the draft provisions contribute to predictability and transparency, the allotted transition period is severely inadequate.

MedicalMountains welcomes the European Commissions initiative to further harmonise and strengthen the implementation of the requirements set out in Annex VII of the MDR and IVDR. The draft Implementing Regulation represents an important step towards improving the predictability, transparency and operational performance of conformity assessment procedures within the EU.

MedTech Europe welcomes the draft Implementing Regulation on MDR/IVDR Annex VII and broadly supports the direction taken. The text introduces important operational provisions which will bring urgently needed predictability, transparency and consistency to the conformity assessment of devices under MDR and IVDR.

COCIR welcomes the draft Commission Implementing Regulation on the uniform application of requirements for notified bodies as a timely and necessary step. The objective of the proposed measures to increase predictability of conformity assessments will foster higher competitiveness of the EU regulatory framework, while ensuring patient safety.

The Federal Agency for Medicines and Health Products (FAMHP) thanks the Commission for the opportunity to react to this Commission implementing regulation laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body. You will find in attachment some comments on the draft text.

The British Dental Industry Association (BDIA) welcomes the proposed changes to the requirements for Notified Bodies. Throughout the implementation of the EU MDR, manufacturers have noted significant inconsistencies in requirements and processes between Notified Bodies, as well as inadequate communication and a lack of transparency, and these reforms should help to address these issues.

SPECTARIS expressly welcomes the draft Implementing Regulation for Annex VII to the MDR/IVDR and sees it as an important step towards further stabilising and strengthening the European regulatory framework for medical devices and in vitro diagnostic medical devices.

Filed in German · English published by the European Commission

EUROM strongly supports the Europeans Commissions initiative to clarify procedural requirements and lay down uniform rules for the conformity assessment under the medical device and in-vitro-diagnostic regulatory frameworks.

Team-NB, the European Association of Medical Devices Notified Bodies, welcomes the opportunity to comment on the draft Implementing Regulation amending AnnexVII MDR/IVDR. We support the goal of improving predictability, consistency and transparency in conformity assessment, but several elements of the draft raise significant legal, proportionality and feasibility concerns.

Dear, Please see the attached file containing the statement from RISE Medical Notified Body regarding the "Draft Commission Implementing Regulation laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by notified bodies designated under Regulations (EU) 2017/745 and (EU) 2017/746".

Confindustria Dispositivi Medici welcomes the proposed delegated act, which responds to long-standing requests to the European Commission to improve clarity, predictability and harmonization in the conformity assessment process. We also appreciate the opportunity offered by this public consultation to reflect the perspective of our member companies.

EURAMET, the European Association of National Metrology Institutes, welcomes the opportunity to contribute to the European Commissions (EC) initiative to lay down rules for applying the requirements to be met by notified bodies- the independent bodies tasked with assessing and certifying medical devices and in vitro diagnostics. Measurement science (metrology) is crucial in underpinning accuracy and standardization.

The Medtech & Pharma Platform Association (MPP) welcomes the proposed EU Implementing Regulation establishing harmonised quality management and procedural requirements for conformity assessment activities performed by notified bodies. We consider the introduction of requirements for reliable quotations, predictable timelines, and transparent monitoring of both timelines and costs to be a positive step.

TÜVSÜD has significant objections to the draft Implementing Regulation on AnnexVII MDR/IVDR, as it introduces new obligations that exceed the legal scope of implementing acts and therefore goes beyond what implementing legislation is permitted to regulate. A central objection concerns the overly prescriptive and unrealistic timelines for individual steps of conformity assessments.

We welcome the efforts to harmonise practices across notified bodies and to enhance transparency and predictability, thereby improving the reliability of both timelines and expected costs for conformity assessments. However, the proposed Article 3 appears overly rigid, especially for high-risk, novel, or rapidly evolving technologies.

Becton Dickinson and Company (BD) welcomes the opportunity to respond to the public consultation on the draft Commission Implementing Regulation laying down uniform quality management and procedural requirements for conformity assessment activities carried out by Notified Body under the IVDR and MDR.

We welcome the European Commissions effort to enhance clarity and improve the existing framework through the proposed revision of Annex VII to the MDR. The initiative clearly reflects an intention to facilitate processes and strengthen legal certainty for both manufacturers and notified bodies.

AESGP, the Association of the European Self-Care Industry, represents the manufacturers of self-care medical devices, non-prescription medicines, and food supplements in Europe, an area also referred to as self-care or consumer healthcare products.

Pharma Deutschland welcomes the European Commission's initiative, which aims to ensure uniform application of the requirements set out in Annex VII of the MDR and IVDR. In support of this initiative, Pharma Deutschland wishes to draw attention to certain aspects of the draft implementing regulation that merit further examination and potential revision.

BVMed is an industry association from germany representing more than 300 manufacturers, suppliers, and distributors in the medtech industry. BVMed welcomes the European Commissions proposal to introduce concrete implementing provisions for Annex VII of the MDR.

The Physikalisch-Technische Bundesanstalt (PTB) welcomes the proposed Implementing Regulation and strongly supports its objective of harmonising quality management and procedural requirements for notified bodies under Regulations (EU) 2017/745 and (EU) 2017/746.

Proposal for a European Commission Implementing Regulation on the uniform application of the requirements to be met by notified bodies designated under Regulations (EU) 2017/745 and (EU) 2017/746 as regards certain quality management requirements and certain requirements for conformity assessment processes.

Filed in French · English published by the European Commission

EuromContact, the European association representing manufacturers of contact lenses and lens care products, welcomes this consultation and agrees with the assessment that MDR implementation has shown inconsistent and divergent interpretations of certain requirements set out in MDR Annex VII, especially as regards the timelines for completing conformity assessment activities and re-certification.

Spanish biotechnology, characterised by a dynamic ecosystem of start-ups, innovative SMEs and companies specialising in personalised medicine and advanced diagnosis, welcomes the Commission’s proposal for a regulation to harmonise the quality management requirements and procedures applicable to notified bodies under Regulations (EU) 2017/745 and 2017/746.

Filed in Spanish · English published by the European Commission

The TÜV Association and IG-NB welcome the European Commission's efforts to harmonise conformity assessment requirements of Notified Bodies operating under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). However, these efforts must not result in requirements being imposed on Notified Bodies that cannot be fulfilled or that create more bureaucracy.

We welcome the efforts to improve consistency and predictability, but it seems that some parts of the proposal are not very realistic, in practice, and could hinder the conformity assessment of complex or high-risk devices and IVDs. Mandatory timelines may risk rushed assessments and higher rejection rates, especially for SMEs that may lack resources to meet these deadlines.

We are in favour of these changes, which will enable the files assessed by notified bodies to be processed in a uniform manner and new medical devices to be placed on the market more quickly. Nevertheless, the coexistence of legacy devices and devices complying with the MDR makes the work of distributors and importers complex to meet their regulatory obligations in terms of documentary checks and physical checks on…

Filed in French · English published by the European Commission

We very much welcome the European Commission’s willingness to further develop the MDR and to address existing challenges in the conformity assessment process. In particular, the proposed regulation aims at increasing the standardisation and transparency of notified body processes. However, in our view, this approach is too short.

Filed in German · English published by the European Commission

Uniform operation of Notified bodies towards manufacturers is more than welcome, but as the manufacturers are under burden of the regulatory requirements, the Notified body will also be, leading to two frustrated parties on the expense of the patients. Structural revision of the current legislation is necessary, with top down approach, not bottom up as this proposal implies.

We strongly welcome the draft implementing regulation. It addresses key structural challenges in the current MDR/IVDR implementation and represents an important step forward, particularly for small and medium-sized enterprises (SMEs) and for manufacturers that will be required to work with a Notified Body for the first time.

The feedback of CE Certiso (NB2409) with regards to the consultation for the Commission's proposal to amend Annex VII of the MDR/IVDR, is as follows. We appreciate the efforts of the Commission to streamline the conformity assessment process and increase the transparency of the system. However, we hereby wish to express our concerns regarding the proposal. 1) Proposed timelines seem to be unrealistic. (Art.

I fully share the objective of this revision. It is indeed essential to adapt the regulatory framework in order to enable companies, particularly SMEs, to cope with requirements that can sometimes be disproportionate, with unpredictable timelines and an administrative burden that has become difficult to sustain.

The EU NB feedback is summarised in slides attached. In summary, our top priorities are: 1. Article1: Quotations There is no reliable mechanism for NBs to confirm SME status, adding administrative burden. SME status should be validated and recorded in EUDAMED during user registration, providing a transparent and consistent verification process for all stakeholders, including NBs. 2.

The focus of Annex VII to be amended is heavily on additional requirements for notified bodies with regard to timelines, clockstops, associated monitoring and reporting, while the substantive requirements for technical documentation, SSCP, PSUR, etc. remain unchanged. It is therefore not expected that the procedures will be accelerated.

Filed in German · English published by the European Commission

It is acknowledged that the proposal intends to speed up conformity assessment processes within notified bodies. While this is an important topic, which we fully support, it does not address the root cause leading to the situation.

As a small designated body with limited human resources, we are critical of the proposed changes. We welcome the objective of increasing transparency and predictability. In practice, however, the administrative burden will increase significantly, especially already at the offer stage. Tender requests can only be assessed in the case of near-final technical documentation.

Filed in German · English published by the European Commission

In principle, I welcome the Commission’s willingness to further develop the MDR. The authorisation of medical devices in Europe currently involves a lot of red tape, long processing times and high costs. The proposed regime can increase the transparency of conformity assessment.

Filed in German · English published by the European Commission

Cruelty Free Europe welcomes the opportunity to provide feedback on the draft Commission implementing regulation, laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council.

The proposed changes address only part of the problems related to the functioning of notified bodies that medical device manufacturers face in practice. In particular, they do not resolve key issues concerning costs, timeliness of activities, and contractual relationships.

Feedback of NB 1023 ITC from 7th January 2026 Document Ref. ARES(2025)11081575 12/12/2025 Draft of Commission implementing regulation (EU) laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council (hereinafter referred to…

This is the response from Kiwa Assurance B.V. (NB 1912), with regards to the consultation for the Commission's proposal, from 12 December 2025, to amend Annex VII of the MDR/IVDR. Acknowledgement is made to introducing maximum timelines and clock-stops for certification activities and it is appreciated that this effort is with the intention of streamlining conformity assessment processes, improving predictability…

Thank you for the opportunity to review the draft proposal. Overall, I find the proposal to be comprehensive and beneficial in achieving the goal of harmonising the timelines and costs associated with the notified bodies review and certification process. Below are my recommendations that may help manufacturers and notified bodies align their expectations regarding costs and timelines.

As a consultant, I support manufacturers in preparing technical documentation. I have been doing this for many years. As a result, the documentation I am involved in often passes completeness checks without comments. That is rarely where the difficulty lies. The problem often starts afterwards.

As a manufacturer of in vitro diagnostic medical devices, which is already certified and has several certified devices, the key issue remains the eternal delay in the assessment of devices. There are constant delays, and unnecessary rounds of questions that prolong the evaluation process infinitely, thus adding to the evaluation expenditure.

Filed in Spanish · English published by the European Commission

The draft contains sensible approaches to harmonise notified body practices. However, it has not been thought through to its logical conclusion. The Unresolved Liability Problem: In its 2017 judgment C-219/15 (PIP/TÜV Rheinland), the ECJ established that the MDD contains no express liability regime for notified bodies and that national liability rules remain applicable. The MDR 2017/745 has not changed this.

1.as a non-EU IVD manufacturer, it's very difficult to provide clinical study on the European population, but for most IVD products, there's no difference among different populations. It's suggested to cancel such population equivalence requirements. 2. it takes so long time to sign the contract with the NB to apply IVDR registration.

As a medical device manufacturer from China, our company has been seeking quotations and cooperation with notified bodies for our Class IIa consumable since 2020. Due to limited notified body resources, it took us five years to finally obtain the MDR certificate in June this yeara process that was excessively lengthy.

Considering that a bottleneck in the certification of medical devices is caused by: - The reduced number of Notified Bodies - The codes of the corresponding types of devices that specify the purpose of the designation the same deadlines and transparency of precesses required of Notified Bodies should also be imposed on Ministries and Accreditation Authorities for the evaluation of applications submitted by CABs.

Notified bodies need to be directed to provide increased transparency and communication surrounding technical documentation reviews conducted by NBs. While I understand there is alot of difficulty in forecasting this until documentation is actually reviewed, this can be a blank cheque to Notified Bodies.

We welcome the draft and support its objective to improve transparency, predictability and consistency in MDR and IVDR conformity assessment activities. Clarifying quotation practices, introducing maximum timelines, and requiring monitoring and publication of performance data address well-known structural issues in the current system.

Positive news on set review timelines. I'm very disappointed that recertifications are still going to be a thing. Let the NB focus on new applications, surveillance, significant changes etc. A little confused also on information having to be provided to NBs on micro/small business status as, unlike in the US, there are no discounts being provided for SMEs apart from on a headcount only basis.

The objective of this draft implementing regulation to harmonise notified body practices, improve predictability, and reduce unnecessary delays under Regulations (EU) 2017/745 and 2017/746 is timely and appropriate.