Medicinal Products – New Medical Device Regulation EU 2017/745 has become into force
The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) came into force on May 26th, 2021. The national implementation is regulatedby the Medical Devices Implementation Act (MPDG). The latter will replace the Medical Devices Act (MPG) in Germany on May 26th, 21st and, like the MDR, is binding for manufacturers, operators and other stakeholders.
In particular, the newly introduced "other clinical trials" are of relevance for researchers with medical products from the scientific environment. As this increases the requirements significantly, we would like to explicitly draw your attention to the changes: The submission must be carried out via the DMIDS (German Medical Device Information and Database System) in order to report to the authorities and obtain an opinion from the ethics committee, to take out insurance and to prove the qualification of the examiner.
The legislature has not formulated the delimitation of the studies completely and clearly. We therefore recommend that you seek advice from the ZKS before approaching the ethics committee. If your study falls under the term “other clinical trials”, MHH must take over sponsorship, which is also coordinated by the ZKS.
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