From December 2024 to March 2025, the EU Commission gave a broad group of stakeholders the opportunity to provide “feedback on the effectiveness, efficiency, relevance, coherence and EU added value of the regulations on medical devices”. The regulations concerned were the MDR and the IVDR.
Just under 60% of the responses came from companies. Almost 45% of all responses came from Germany and France alone.
According to the published report, the assessment of the MDR, disregarding individual contributions from the general public, can be summarised as follows:
Just under half of the respondents believe that the MDR contributes to the safety of patients and users. At the same time, a large share of companies criticise the fact that the MDR has had no positive effects on the EU’s capacity for innovation and competitiveness.
Few see the MDR as creating a genuine single market with a level playing field for everyone, because company size and market position continue to create inequalities in particular.
On the positive side, respondents highlighted the advantage that the MDR removes the need to comply with different national regulations within the EU: around half of those surveyed said this gave them lower compliance costs. Nevertheless, the costs associated with the MDR requirements are predominantly regarded as high and unacceptable, above all in the phase before a medical device is placed on the market.
The final report can be downloaded here: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14155