We are delighted to share with you the attached just-published MedTech Europe final survey report, “Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation”. You may also access it on the MedTech Europe website. Please feel free to share it with your members and contacts as you wish.

The survey was commissioned by the Medical Device Coordination Group (MDCG) Task Force on Certification Capacity Monitoring to assess the availability of medical devices (MDs) in 2022 in connection to the MDR implementation. As such, the MDCG drafted part of the questions included in the survey. MedTech Europe included additional questions with the aim to cover some areas that were not tackled by the MDCG questions.

As recently discussed, a high number of MD manufacturers have participated in this exercise and we estimate the results to reflect around 60-70% coverage of the total revenue of the European MD market. The responses by the companies that participated to the survey lead to some of the following key conclusions:

  1. MDR certificates have not been issued yet for >85% of the >500,000 devices previously certified under the MDD or AIMDD
  2. 54% of survey respondents said that they do not intend to transition some of their portfolio to the MDR. All product categories are impacted by potential device discontinuations.
  3. Small and Medium Enterprises (SMEs) face more challenges in MDR implementation than larger companies. At least 15 % and up to 30% of SMEs still have no access to an MDR-designated Notified Body. For SMEs progress to MDR certification is slower than average.
  4. MDR is currently a disincentive against launching medical device innovation in the EU: approximately 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.

We are also sharing the survey report with other MDR stakeholders and relevant policymakers.