The guidance document MDCG 2021-4 has been updated. For context, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers of class D in vitro diagnostic medical devices (IVDs) are required to submit their applications to a notified body as part of the conformity assessment process. Additionally, under certain conditions, specific elements of the assessment may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL).
The guidance document, initially published in 2021, provides indications for how to apply the IVDR provisions related to expert panels and EURLs before the IVDR application date, i.e. 26 May 2022, as well as around the time when the first EURL designations become applicable for the purpose of EURL tasks.
Most notably the changes to this document include the following:
- Q1 Indication that question is obsolete
- Q2 Minor revision
- Q3 Introduction of reference to MDCG 2021-22 Rev 1
- Q4 Editorial change
- Q5 Minor revision
- Q6 Revision
- Q7 New question
The updated guidance can be accessed using the following link
