MDR tanfolyam_medical_and_healthcare

View of notified bodies on the MDR and IVDR review process

The European Commission has published a Call for evidence from stakeholders in the healthcare industry, inviting them to share their opinions on and experiences of applying regulations for medical and in vitro diagnostic (IVD) devices. The EU Commission’s initiative aims to increase the sector’s competitiveness by simplifying the rules and making safety requirements more proportionate and cost-effective, while ensuring patient safety and maintaining high healthcare standards. Since early summer 2025, the notified bodies (including both Team-NB and non-Team-NB members) have been working together to develop a proposal that they hope the Commission will take into account as part of the review procedure.

Six working groups have been set up to address the following topics:

  1. Introduction of early dialogue
  2. Clarification of Article 61(10) and WET
  3. Application of digitalisation processes
  4. Modification of the coding structure in the MD and IVD areas
  5. Designation and recertification
  6. New breakthrough devices

The proposal was divided into five sections:

  1. Summaries of each task force
  2. Annex I: Proposed legislative text amendments based on outputs of the six working groups
  3. Annex II: Proposed coding structure for medical devices and IVDs
  4. Annex III: Background information and written proposals for each task force
  5. Annex IV: Abbreviations
a) Early dialogue

Notified bodies suggest that a system of early dialogue should be developed in addition to the current structured dialogue in order to improve the transparency of the conformity assessment process. Early dialogue would allow manufacturers to identify potential gap before the full conformity assessment, thereby speeding up the time to market for products. This would benefit manufacturers, notified bodies, and patients, who would have faster access to medical devices.

b) MDR Article 61(10) and well-established technologies (WET)

The current MDR requires clinical data to be provided for all medical devices, even if it may not be appropriate. However, the applicability of Article 61(10) has been the subject of debate between manufacturers and notified bodies in certain cases.

The following proposed amendments aim to ensure the necessary balance between clinical and non-clinical data to guarantee the safety, clinical benefits and performance of devices. These amendments will improve clarity and effectivenes in conformity assessment.

  • Redefinition of the criteria for the applicability of Article 61(10) in order to narrow its scope and clarify its application.
  • Extension of the definition of clinical data (Article 2(48)) to include real-world evidence, post-market data and relevant international sources.
  • Redefinition of clinical evaluation (Article 2(44)) and clinical evidence (Article 2(51)) to include clinically relevant non-clinical data.
  • Clarification that clinical evaluations are generally based on clinical data but may also include other relevant data.
  • Issuing MDCG guidance that reflects a more holistic understanding of ‘sufficient clinical evidence’.
c) Digitalisation

Digitalisation and the development of artificial intelligence offer opportunities to support the creation of more cost-effective assessment processes and enable the simplification of assessments carried out by notified bodies.

e) Designation and reassessment

  • The designation process should be simplified and shortened.
  • When extending the scope of an already designated notified body, the original designation process should not be applied; the focus should solely be on the extension of scope.
  • In the event that a notified body ceases its activities, a controlled transfer of certificates should be required to avoid the need for complete reassessment.
  • Clearer expectations should be set out in relation to the review of rules and qualification criteria.
e) Kijelölés és újraértékelés
  • A kijelölési folyamatot egyszerűsíteni és rövidíteni kellene
  • A már kijelölt bejelentett szervezet hatályának kiterjesztése esetén ne az eredeti kijelölési folyamat alkalmazzák, csak a hatály kiterjesztése legyen a fókuszban.
  • A bejelentett szervezet tevékenységének megszűnése esetén a tanúsítványok ellenőrzött átruházására van szükség, elkerülve a teljes újraértékelés kötelezettségét.
  • A szabályokkal és a minősítési kritériumok felülvizsgálatával kapcsolatosan egyértelműbb elvárásokat kellene meghatározni.
f) Products classified as ‘breakthrough’

A coordinated procedure system should be introduced whereby the European Commission or its expert panels would be responsible for granting designation ‘breakthrough’ to a given product. This would allow the notified body to issue conditional certificates, requiring the manufacturer to gather further evidence on the use of the device after it has been placed on the market. Clear management and supervision of the system is essential.

Author: dr. Katalin Tauberné Jakab (Clinical Expert, NoBoVersum)

Forrás: https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/