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MedTech Europe survey shows certification timescales at all-time high

MedTech Europe has published a report following a survey of its members to analyse the availability of medical devices in 2022 in connection to the implementation of the new EU Medical Device Regulation (MDR). 

A total of 475 companies (373 SMEs and 102 large companies) were surveyed throughout April 2022 by the Medical Device Coordination Group (MDCG) Task Force on Certification Capacity Monitoring. 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 over 85% of the more than 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 not prioritising the EU market (or will not) as the geography of choice for first regulatory approval of their new devices.

The conclusion of the survey outlines that few devices have so far successfully transitioned to MDR with timescales for medical device certification at an all-time high, and MedTech Europe warns that legacy devices across all categories will disappear from the market between now and May 2024 – the end of the transition period.

The conclusion states: “In addition to the disappearance of legacy devices, the survey data clearly shows that innovation is already leaving Europe. This too, MedTech Europe fervently believes, must also be course-corrected, otherwise the clinical benefits of new and improved device designs will become preferentially available to patients in third countries first, requiring patients based in the EU to wait for the MDR system to become ready.

“This survey clearly indicates an urgent need for immediate action by decision-makers to help keep needed medical devices available in Europe.”

You can read the full survey report here.

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