There has been a lot of uncertainty surrounding the EU MDR (Medical Device Regulation (2017/745). Amidst the COVID-19 Pandemic and following requests by several European associations, the European Commission (EC) recently announced that it plans to delay the deadline by one year. The lack of Notified Bodies^ (as of March 2020, there were 12), and the fact that Coronavirus could cause significant bottlenecks in the MedTech market (e.g. if certain device certificates cannot be renewed on time) were just some of the reasons for the requested delay. Our recently published MDR survey results show how well prepared MedTech companies actually were for the MDR.
On February 26, 2020, we set out to assess the state of implementation of the EU MDR requirements among MedTech companies in Europe. Our EU MDR Readiness survey consisted of 14 questions and closed on March 25, 2020. Although we have participants from all over Europe, the majority (86%) came from the German-speaking region. 110 companies took part, most of them (85%) medical device manufacturers.
Summary of EU MDR Readiness Survey Results
Overall, the results show that only few companies were ready for the new regulation in terms of their Post-Market Surveillance, Quality Management Systems, Notified Bodies and clinical data capture systems:
- More than three quarters (77%) consider the new regulation to be “very challenging“
- The main challenges identified were “lack of clarity regarding the new requirements” and “increased resources and costs”
- Around one third believe that EU MDR will cost more than 5% of their annual turnover
- Only 26% have a fully MDR-compliant QMS
- 34% do not yet have a Notified Body or are currently switching NBs
- Almost half do not (yet) have a PMS plan
- Many companies still use paper (48%) and/or Excel spreadsheets (69%) for clinical data collection (multiple selections possible)
Download the Results
We’re curious to see what the coming year will bring for MedTech and hope that you will enjoy browsing through this slide deck. If you have any questions or feedback, please feel free to contact us at email@example.com.
In the meantime, here are some additional MedTech papers you might enjoy: