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New Guidance Related to IVDR Issued Covering High Risk IVDs

NEW YORK – A European Commission group this week issued new guidance related to the In Vitro Diagnostic Regulation, the new law governing the regulation of IVDs that is set to come into effect in Europe later this year. The Medical Device Coordination Group, a European Commission working group created to address issues in the medical device sector, published the document on Feb. 15.

The guidance concerns the verification of class D IVDs by designated certification bodies, called notified bodies. Class D devices are considered to be the highest risk IVDs, and encompass tests for infectious diseases, for example, as well as some blood grouping tests. The guidance lays out guidelines on how notified bodies should carry out batch testing of manufacturers' Class D devices as part of conformity assessment.

Specifically, the guidance calls for NBs to partner with EU reference laboratories to undertake batch testing to verify batches of class D tests. The guidance also provides a blueprint for the verification process, including what kinds of agreements are necessary between NBs and device manufacturers. For each IVD, the MDCG also recommends the creation of a testing plan to be shared with the reference laboratory. The guidance provides further suggestions on how to arrange batch testing between all parties involved.

The IVDR will come into force in May, five years after it was enacted. However, given a dearth of regulatory capacity, coupled with pandemic-related constraints in implementing the regulation, the European parliament voted in December to stagger the grace periods for tests cleared before the May 26 date. Any tests that do not have a CE-IVD mark prior to May 26, however, will require assessment by a designated NB under the IVDR.