Tuttlingen/Brussels - The survey "Analyzing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation" was commissioned by the MDCG Task Force on Certification Capacity Monitoring and carried out in April of this year. According to MedTech Europe, the 475 responding companies operating in the EU cover between 60 and 70% of the total market turnover, so the quality and quantity of the data collected allows for informed conclusions.
The most important results are mentioned:
- MDR certificates have not yet been issued for more than 85% of the more than 500,000 products that were previously certified according to the MDD or AIMDD.
- Larger companies are actively submitting MDR applications. The examination of 70% of the submitted applications is still ongoing.
- The average time to certification by Notified Bodies is 13 to 18 months - twice as long as previously under the guidelines.
- More than 50% of respondents plan to downsize their portfolio. At these companies, around a third of the products are affected by potential obsolescence, across all categories.
- At least 15% and up to 30% of small and medium-sized companies still do not have access to an MDR-certified Notified Body.
- Around 50% of respondents no longer prioritize the EU market for the initial registration of their new products.
- More than 20% of respondents attribute delays in MDR certification to the release of new or revised MDCG guidance.
The figures confirm that a worrying development can be seen throughout the EU, as was already determined at a more national level in the joint survey by MedicalMountains GmbH, SPECTARIS and DIHK. The parallels are clear with regard to the duration of certification, product discontinuations and the first approval of products in the European Union, among other things.
MedTech Europe's full survey can be accessed at this link.
