IVDR Certification of Class D devices, Implementation Plan and MDR NB

The MDCG released an important Q&A for manufacturers of Class D devices and their certification during the transition period - until 26 May 2022 or the IVDR date of application. The document is particularly relevant for those types of devices that will undergo an additional scrutiny as part of their conformity assessment procedure, e.g. review by an expert panel or/and test by EURL [EU reference laboratory]. Below an extract of the MDCG Questions & Answers . . .

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