MedTech Europe survey shows MDR potentially hampering innovation
MedTech Europe has published a report analysing the availability of Medical Devices in 2022 in connection to the EU Medical Device Regulation (MDR) implementation.
A total of 475 companies (373 SMEs and 102 large companies) were surveyed throughout April 2022 by the Medical Device Coordination Group (MDCG) Task Force on Certification Capacity Monitoring. The survey represents an estimated 60-70% market revenue coverage.
The participating companies' survey answers resulted in the following key figures:
- The time-to-certification with MDR-designated Notified Bodies is taking 13-18 months on average. This is double the time historically needed for certification under the Directives.
- Up to 30% of SMEs have either no Notified Body (15%) and/or have a Notified Body that is not yet designated to MDR (15%).
- MDR certificates have not been issued yet for more than 85% of the 500,000+ devices previously certified under the MDD or AIMDD.
- 50% of respondents are deprioritising the EU market (or will do so) as the geography of choice for first regulatory approval of their new devices.
- More than 20% of respondents attribute delays in MDR certification to the publication of new or revised MDCG guidance.
The conclusion states: "The implementation of MDR in the EU is having a serious effect on the EU medical device market. This will be felt by EU patients and health systems."
"With less than two years remaining until 26 May 2024, few devices have so far successfully transitioned to the MDR, and timescales for medical device certification are now at an all-time high."
"This survey clearly indicates an urgent need for immediate action by decision-makers to help keep needed medical devices available in Europe."
You can read the full survey report here.