The MD Regulation (MDR) 2017/745 is a recent EU directive on medical devices which entered into full force on 26th May 2021 after a transition period of three years, extended in early 2020 for a fourth year due to the COVID-19 crisis. Since 26th May 2021 all new or legacy medical devices must meet the new, modernised and more stringent requirements of the MDR to continue being placed on the market in the future.
Now, more than one year under the MDR regime, Medtech Europe has conducted a survey on 475 respondents (373 SMEs and 102 larger companies) on how MDR is affecting their commercialization strategy, and the results are, to say the least, not ideal.
Here are some of the key data figures from the survey:
• The survey represents an estimated 60-70% market revenue coverage.
• MDR certificates have still not been issued yet for >85% of the >500,000 devices previously certified under the MDD or AIMDD1.
• Larger companies are actively filing under MDR. Review is still ongoing for 70% of submitted industry applications.
• The time-to-certification with MDR-designated Notified Bodies is taking 13-18 months on average. This is double the time historically needed for certification under previous Directives.
• >50% of respondents plan portfolio reductions. 33% of these companies’ medical devices are currently planned for discontinuation.
• All product categories are impacted by potential device discontinuations.
• At least 15 % and up to 30% of Small and Medium Enterprises (SMEs) still have no access to an MDR-designated Notified Body.
• ~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.
• >20% of respondents attribute delays in MDR certification to the publication of new or revised MDCG guidance.
Clearly, few products have so far successfully made the transition to the MDR, and timeframes for medical device certification are presently at an all-time high, with less than two years till 26 May 2024. MedTech Europe forecasts that legacy devices across all categories will vanish from the market between now and May 2024 if the scenario revealed by this data is not immediately course corrected.
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