New MDR and IVDR guidance documents published by MDCG and MedTech Europe

mdi Europa is constantly screening various sources on news and guidance that could be of importance for medical device manufacturers. In this context, we came across two guidance documents that have recently been published.

  • The Medical Device Coordination Group (MDCG) has issued MDCG 2020-10. This guidance provides suggestions for safety reporting in clinical investigations conducted under Regulation (EU) 2017/745 on medical devices (MDR). Please let us know should you be interested in obtaining a copy.
  • The industry association MedTech Europe has issued a guidance document for clinical evidence requirements for CE certification under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Although the document focuses clearly on class B, C and D devices, it may also be worth for manufacturers of class A devices to review the document. 

As always, should you have any questions or comments on these topics, please let us know.

Sources: MDCG and MedTech Europe guidance documents

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