On January 6, 2023, the EU Commission adopted a proposal to allow more time to certify medical devices according to Regulation (EU) 2017/745. This decision is aimed at mitigation of the risk of medical devices’ shortages. For many manufacturers the news came as a big relief. Also, for some notified bodies struggling with the overflow of applications it was positive news.
According to recently published statistics, the number of MDR applications launched by medical device manufacturers exceeded the number of issued certificates
- sixfold in 2021 and
- fourfold in 2022,
while the certification process for about 70% of applications took from 13 to 18 months.
Comparing a total of 22,793 issued MDR certificates expiring by 2024 and the time required for the certification process, one can see that the existing capacity and speed of work of notified bodies will continue to stand in conflict with the amount of expected applications.
In 2022, we boosted our MDR auditing resources in Germany and are therefore able to take on new clients at short notice.
Our Notified Body, SGS Fimko Oy, offers MDR certification for active medical devices in a wide scope of notification.
Please contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. for details of the MDR certification process – we will contact you immediately.
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Contact
Armin Hudetz
t: +49 89 787475-133
f: +49 89 12504064-133
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Customer Service Team
t: +49 89 787475-222
f: +49 89 12504064-100
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