European Commission Publishes Guidance on High-Risk IVDs During Transition Period

The European Commission’s Medical Device Coordination Group has released guidance for manufacturers of high-risk Class D in vitro diagnostics (IVDs) during the EU’s transition period for its In Vitro Diagnostic Regulation (IVDR), which will go into effect May 26, 2022.

Under the IVDR, manufacturers of high-risk Class D IVDs must submit applications to notified bodies for conformity assessment, but they also may have to be reviewed by an expert panel and/or be tested by an EU reference laboratory (EURL).

Expert panels will provide their views to the notified body “within the deadline for delivery of the scientific opinion by the EU reference laboratory,” the guidance says, noting that if no EU reference lab is designated for the device, the expert panel “should provide its views within 60 days.”

Establishing the EURLs for a range of Class D devices has been identified as an important priority and the commission is working on introducing the criteria and fees for the EURLs.