Document paper New medtech regulations

MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation

During the month of April 2022, MedTech Europe members participated to a survey commissioned by the Medical Device Coordination Group (MDCG) Task Force on Certification Capacity Monitoring to assess the availability of MDs in 2022 in connection to the Medical Device Regulation (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.

The responses by the companies that participated to the survey lead to the following 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.

Posted on 15.07.2022

Related content