21. Juli 2022 – MedTech Europe conducted a survey with 475 responses across large companies and SMEs to quantify the availability of medical devices. The results show that less than 15% of medical devices have already received MDR certificates. Time-to-certification has doubled to 13-18 months and more than 15% of SMEs still have no access to an MDR-designated Notified Body. As a result, nearly half of the respondents say they will deprioritise the EU market for first regulatory approval of new devices.

The survey is available here.