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Wednesday, March 19th

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4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746

The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746. The main changes include examples relating to several of the rules mentioned in the document.

DOWNLOAD THE MDCG 2020-16 Rev.4

4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746

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