The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.

The Commission aims to assess the performance of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Anyone interested in giving feedback to the Commission must do so by 21 March 2025 using this link.

The results of this consultation may not provide any quick or easy solutions to the difficulties that have been encountered as a result of the MDR and IVDR. However, it is an opportunity for the European Commission, and later the EU legislators, to reconsider objectives, understand the needs and difficulties of the industry and set realistic targets for all stakeholders. 

Purpose of evaluation

The European Commission is required under Articles 121 of the MDR and 111 of the IVDR to conduct an evaluation of the legislation by May 2027. However, calls for a targeted evaluation to be undertaken before this date have been growing as a result of numerous amendments and extensions to the transitional provisions, the slow designation of notified bodies, the complaints expressed by thousands of manufacturers and a general concern that the EU medical devices market is becoming less innovative. As part of this, and as set out in a previous blog, the European Parliament recently adopted a resolution on the urgent need to revise the MDR and the IVDR.

In reality, both regulations were adopted by the EU legislators with the best of intensions to increase the safety and oversight of medical devices, but unfortunately failed to balance expectations with the reality of implementing the provisions. Soon after adopting, at the beginning of 2020, it became obvious that manufacturers were not ready for the date of application, but that neither were national authorities or notified bodies. Four years later, many problems remain unresolved and the European Commission is now trying to understand what went wrong. It has been questioned whether this consultation is necessary given the amount of debate about the problems with the legislation. However, due to the mechanisms the European Commission has to go through in order to amend legislation such as this, and the fact that it relies on an understaffed team in DG SANTE expected to manage a growing regulatory crisis, such a consultation is a necessary step in the process.

Questionnaire

The questionnaire is available here and accessible after registration on the European Commission’s website. Different questions are asked depending on the relevant stakeholder. Several topics are discussed and we anticipate that companies will need to allow a good amount of time to respond to all of the questions. You can also see feedback from other stakeholders on the consultation site.

The Commission is requesting feedback from anyone interested, including scientific researchers and  academic organisations.

It is, however, essential that medical device manufacturers provide their input, as they are the ones who are most affected and who are required to apply the long list of MDR and IVDR requirements in order to market their devices. It is equally important that companies from the pharmaceutical sector, who are dependent on medical devices for the administration of their medicinal products, take the time to participate in this survey.

The consultation does not end with the questionnaire and the call for feedback. The following actions are also scheduled by the European Commission:

• A set of targeted consultation activities tailored to particular stakeholder’s groups, including workshops.
• Consultations of the Medical Device Coordination Group in order to complement the consultation process.
• A stakeholder conference to further complement the process.
• Particular focus on SMEs and ways to ensure appropriate engagement are being explored.

The Commission has stated that all input will be taken into account and a report of the comments will be published once the consultation has closed.