Certification status for medical devices: Evaluation by the EU Commission from August 2025

On August 1, 2025, the European Commission published an updated evaluation of the data collected by notified bodies on applications and issued certificates in accordance with MDR and IVDR. This survey is based on the status of February 28, 2025 and takes into account feedback from 51 notified bodies.

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Key results of the evaluation:

• Applications and certificates:
  There were 28,489 MDR applications and 12,177 MDR certificates. Compared to the last survey (May 2025:28,069 applications, 10,554 certificates), there is a slight increase in certificates and applications.
• Specific regulations:
  For individual regulations, such as Rule 14, 827 applications were submitted and 228 certificates issued; under Rule 21 (first indent), there were 171 applications and 7 certificates.
• Processing times:
  On average, it takes less than two months from application to written agreement with the notified body (feedback from 50 notified bodies). A new evaluation shows for the first time: In the entire certification process, 42% of the processing time is spent by the notified body and 58% by the manufacturer.
• Total duration of certification:
  For 60% of submissions, it takes 13-18 months for an MDR certificate (QMS+product) to be issued (October 2024:56%). For 92% of submissions, the processing time is more than 13 months (October 2024:94%).
• More details:
  The evaluation provides a differentiated overview by attachment, type of application (QMS versus product), reference to the rules and information on the distribution of process times and changes since the last survey.

Conclusion:
MDR certification remains a bottleneck for manufacturers, in particular due to the long overall processing times, for which the manufacturers themselves are responsible for more than half. Only slight progress in the number of certificates issued points to continuing challenges in implementing regulations and accessing the European medical device market.

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