Recertification of medical devices

In our blog post of 26 May 2021, we informed on the EU Medical Device Regulation ("MDR") and the German Medical Device Regulation Implementation Act ("MPDG") entering into force. In that blog post, we pointed out that there would be no exemption for existing certifications. Therefore, medical devices which had been certified before the MDR entered into force are generally required to be retested and recertified under the new requirements. Article 120 MDR has determined transitional periods, stipulating in paragraph 2 that certificates issued after 25 May 2017 will become void at the latest on 24 May 2024.

The Federal Association for Medical Devices ("BVMed") recently emphasised that around 30% of medical devices could therefore 'disappear' from the market because the new regulatory system of the MDR lacks the capacity to certify existing products in due time and the documentation effort for existing products has increased dramatically. This concerns various products, such as surgical materials, but also plasters, glasses and rapid antigen tests.

These problems arising out of the implementation of the MDR were discussed at detail at the EPSCO meeting held by the health ministries of the European member states on 14 June 2022. A solution to the problems is however not at sight. While the postponement of deadlines and the expansion of resources at the notified bodies are being discussed, legal adjustments or amendments to the MDR do not yet exist.

It is therefore important to have existing products recertified in a timely manner.
Please feel free to contact us now if you have any questions.

Moritz Kopp
Dr Silke Dulle