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New survey on the capacity and experience of notified bodies

On 25 July 2023, the European Commission published a Notified Bodies Survey on certifications and applications (MDR/IVDR). The data presented describes the situation as of 31 March 2023, with 39 out of 39, i.e. 100%, of the notified bodies surveyed (hereafter referred to as "NB"). Of the NB contacted, 38 were reported for MDR and 10 for IVDR. What can we learn from the survey?

MDR statistika oznámený subjekt porta medica

In the field of IVDR, there is not yet a significant disparity between the number of applications submitted and certificates issued. However, the total number of certificates to be replaced is a completely meaningless figure in the case of IVDR, as the problem concerns devices that previously did not need to be certified. At EU level, no one still seems to know how many IVDR certificates will need to be issued. Statistics are missing.

In the MDR area, in the five months between October 2022 and March 2023, the number of applications for certification rose by 40%, while the number of certificates issued rose by 48%. However, the optimism is spoiled by the absolute numbers - the number of applications rose to 11,418, while the number of certificates issued rose to 2,951. Beyond the survey, it can be estimated that something in the order of 21,000 certificates should need to be replaced to date. If we start from today's number of NBs and count 5.5 years until the end of the transition period (I know this is a very rough estimate), each NB should produce one certificate every 3 days in the following period. This is only realistic with a significant capacity of parallel teams working within the NB. It typically takes 6 to 12 months to issue a new MDR certificate, with 13 to 18 months being the second most common. In general, QMS certificates are "done" faster than the combination of QMS + product certificate. Approximately 10% of certificates were issued within six months, which is great.

Perhaps the most important finding from the published data is this: The time between the application and the signing of the certification contract is most often (68% of cases) between 2 and 6 months. About 26% of the contracts were signed within a shorter timeframe of 1-4 weeks, while 6% of the contracts took more than 6 months. Hence the need not to leave the application for May 2024, as with the increased interest in signing contracts, it might not be possible to sign a contract with NB by September! Failure to sign a contract by the September deadline would result in the manufacturer losing the ability to continue to market legacy devices.

Author: Aleš Martinovský


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