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EU Group Issues New IVD Guidelines

NEW YORK – The European Commission's Medical Device Coordination Group this week published new guidelines concerning the implementation of the In Vitro Diagnostic Regulation (IVDR).

MDCG includes representatives from all EU member states and is chaired by a representative of the European Commission. The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.

Under the IVDR, most molecular tests require clearance from a government-accredited organization, called a notified body, which will review the test maker's submission before the test can be put into clinical use. The regulation, enacted in 2017, also calls for governments to apply a sampling method to assess the performance of NBs for evaluating certain classes of devices.

The new MDCG guidance provides criteria for drawing up a sampling plan, and the type of data to be collected prior to issuance of quality management system certificates, as well as afterward during surveillance. The eight-page document also provides more information on assessing technical documentation.

Europe is in the midst of transitioning to a new regulatory framework for medical devices and IVDs. In October, the EC certified Berlin-based Dekra as a notified body for overseeing compliance with the IVDR, the first NB to achieve the designation.