Medical Devices Regulation (MDR) implementation – MedTech Europe Survey

Since 26 May 2021, the Medical Devices Regulation (MDR) has come into full application. Within the framework of new MDR advocacy efforts, MedTech Europe and its members have identified priority areas that lead to an unpredictable and innovation unfriendly regulatory system. These include e.g. challenges when transitioning Directive certificates, lack of Notified Body capacity, fragmented MDR implementation across Europe, implementation of guidelines, innovation, etc.

MedTech Europe now needs concrete evidence / data to illustrate these points. We are therefore reaching out to our members (corporate members as well as national associations and their members) with a request to fill in a survey by 25 April 2022 (EOB).

The survey, which was partly drafted by regulatory Authorities and partly drafted with the help of members, includes two core sets of questions

• Part 1: aimed at assessing the capacity of Notified Bodies; these are questions from Authorities, i.e., the Medical Device Coordination Group (MDCG) Task Force on certification capacity monitoring
• Part 2: additional questions drafted by MedTech Europe.

MedTech Europe strongly encourages all members to reply to the survey. Our aim is to provide regulatory Authorities with a realistic picture of the state of the MDR implementation and your feedback is therefore of utmost importance.

Acting in full compliance with EU competition law, and within its limits, MedTech Europe will keep any company specific information (raw data) collected strictly confidential and under no circumstances will disclose individualized company level information. We will share aggregated, company anonymous survey outcomes with responders of the survey and third parties, including but not limited to Regulators, legislators, and relevant stakeholders (e.g., Notified Bodies).

National associations may get access to individualized company data, if companies request a copy of their replies in the survey – MedTech Europe will then share a pdf version of the company replies (which can then be forwarded to the respective national association directly by the company).

Survey practical information:

• Deadline for reply: Monday 25 April 2022 (EOB)
• Access the survey here: https://www.surveymonkey.com/r/MDR_implementation
• Kindly provide only ONE answer per company.
• We have distributed a word document of the survey questions to help you compile data from several of your company divisions. It is important to note that answers submitted through means other than Survey Monkey (e.g., submissions in WORD or PDF format) will not be accepted.

If you have any questions or enquiries, please contact Jana Russo at regulatory@medtecheurope.org.

This exercise is of crucial importance in our future advocacy efforts, and we need your help! Thanks very much in advance for all the time and effort you’ll invest in this survey.

CONSULTER L’ENQUETE