Survey results on the Postponement of the Medical Devices Regulation

A survey on the postponement of the Medical Devices Regulation (MDR) was supposed to find out what benefit it provides for Notified Bodies and industry - and what problems there are still to be solved.

What is it all about? The Medical Devices Regulation should have come into force on 26 May 2020 with some tightenings. Due to the Covid-19 pandemic, the EU had decided to postpone this date by one year to 26 May 2021. What consequences does this have for the industry?

In total, 18 responses came from companies of different sizes (1-10 employees up to more than 500 employees and covering a broad range of products (combination products, only medicinal products, only medical devices, substance-based medical devices, consultants). Based on the data available (not all questions were answered), it is not possible to make a statistically sound evaluation. But there are interesting qualitative statements.

Postponement of MDR - is there enough time?

Most of the survey respondents are satisfied with the postponement in itself and also with the period of one year. Two participants, however, respectively wished for a longer postponement to 3 years and 2-4 years. But there were also critical voices:

• who is not ready is rewarded - who has done his homework is punished
• EU authorities and Notified Bodies hide negligence
• Projects are stopped

The postponement of 1 year is also considered sufficient for the Notified Bodies. However, 5 respondents would have liked more time for this as well. It is noticeable that half of the respondents work with Notified Bodies that are already certified according to the MDR.

What remains to be done?

The answers to the open question "What do you see as remaining to be done to meet the requirements of MDR by 2021" are particularly interesting. The following answers are summarized:

• Authorities and Notified Bodies: (4x, Authorities and Notified Bodies are not yet ready / Sufficient number of Notified Bodies with the corresponding capacities)
• UDI issue (3x, implementation of UDI for class III products, clear definition and specifications for UDI data including transmission into a system, body where UDI should be listed does not yet exist)
• No examples have been documented yet of how products can be successfully approved according to the MDR
• Clinical evaluation and clinical trial

Conclusion

The participants are largely satisfied with the postponement of MDR by one year. The readiness of the authorities and Notified Bodies and the UDI issue are still viewed critically.