EU Commission addressing MDR and IVDR challenges
Posted on 05.10.2022
The situation surrounding MDR and IVDR is reaching a critical tipping point and all possible efforts must be thoroughly pursued in the interest of safeguarding continuity of patient access to medical devices and IVDs.
MDR certificates have not been issued yet for >85% of the >500,000 devices previously certified under the MDD or AIMDD and at least 15 % – 30% of SMEs still do not have access to a MDR-designated Notified Body (see MedTech Europe’s recent survey on MDR implementation). For IVDR, extended transitional provisions exist to help safeguard the IVD legacy devices. At the same time, it should be noted that with only seven designated Notified Bodies available, IVD manufacturers continue to face issues when it comes to IVDR certification, for current as well as innovative/new devices. Furthermore, there are obstacles to the certification of class D devices and companion diagnostics.
Given this, it is necessary to explore all possible avenues within the legal text to reduce the administrative burden for Notified Bodies so that they can focus their limited resources on issuing as many MDR/IVDR certificates as possible. To that end, it can be positively noted that the MDCG is already looking at non-legislative options. MedTech Europe welcomed the opportunity to comment on the draft MDCG proposed solutions under MDR and IVDR.
Overall, MedTech Europe agrees and supports an overwhelming majority of solutions proposed in MDCG guidance 2022-14, as these could increase the industry’s access to Notified Bodies, address Notified Body capacity issues, and help prevent disruption to devices. However, we see the need for further discussion and clarification on the practical implementation of details (e.g. actual measures, timing, empowerment of stakeholders to implement measures, etc.) of all proposed MDCG solutions.
- Speed is of the essence. Solutions that will become operational only after the end of the year risk bringing diminishing returns because many MDD certificates are already beginning to expire due to the many constraints in the system resulting in lengthy review times for MDR certification. Despite the noted measures, the likelihood of market disruption is very high.
- We believe that the options currently on the MDCG’s table are not sufficient, given the magnitude of the structural challenges holding the MDR and IVDR back. When it comes to MDR, MedTech Europe believes that additional measures are needed to ensure solutions work for all devices (whether legacy, new, or significantly changed). These are likely to include legislative measures, to be further elaborated by the co-legislator.
MedTech Europe will continue to actively engage in discussions and closely monitor the situation of MDR/IVDR implementation over the coming weeks.
For more information, please contact Merlin Rietschel, Senior Manager Medical Devices.