Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force on 26 May 2017 and replaced the three directives (MDD, AIMDD and IVDD)1 that had applied until this date. The European Commission plans to start an evaluation of these two regulations with a public consultation still in 2024. Based on its findings, it will then decide whether the MDR and IVDR need to be revised.
The TÜV Association is of the opinion that the MDR and IVDR have only partially achieved their goal of “establish[ing] a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health while supporting innovation” (cf. Recital 1 MDR). Since coming into effect, there have repeatedly been interpretation issues, a need for amendments and delays in all areas (notification procedure, setup of the EUDAMED database, implementation of the new requirements by manufacturers, etc.).
A revision of the two regulations therefore seems necessary. However, the desire to improve them must not lead to even more bureaucracy, which increases costs, delays market access and has no positive impact on patient safety. Rather than an in-depth revision of the regulations, the European legislator should instead make targeted modifications through individual, concrete and consistent measures. New provisions should merely fill existing gaps and correct previously incorrect or impractical requirements.
The TÜV association recommends the following measures
- No further extension of the transition periods
- Retention of the re-certification requirement
- Further harmonisation of the notification procedure and regulatory requirements
- End to the regulatory overload and creation of a stable legal framework
- Exemptions for innovative/niche products and applications
- Creation of a legal framework to allow “structured dialogues”
- Further exemptions from clinical investigations
- Improvement of the system’s efficiency
- Integration of requirements from horizontal legislation into the MDR and IVDR
- Further digitalisation of market access procedures
