The National Working Group (NAKI) was created to answer questions on the implementation of the EU regulations, the MDR and the IVDR.
Medical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.
MDR's classification rule 11 is a nightmare: It will be a major issue for manufacturers of medical device software. Read what's new and why the EU commission needs to act.
Article about german Regulation
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