IVDR transition for class D assays reaches its final stage

The extended transition period for class D in-vitro diagnostics has now run out. Assays covering blood grouping, transfusion safety, and detection of high-risk transmissible agents need a certificate issued under Regulation (EU) 2017/746 before they can be placed on the Union market, regardless of when their previous national approval was granted or how long the device has been in routine clinical use.

Laboratory associations have flagged a limited but clinically sensitive gap. A handful of low-volume assays, notably confirmatory tests for rare infectious agents and certain tissue typing reagents, attracted no notified body interest because the commercial case for certification is thin. Hospitals relying on those tests are now looking at either validation of an alternative method or in-house development under the health institution exemption.

In-house tests prepared and used within a single health institution fall outside the IVDR provided the institution meets the conditions set out in Article 5(5). Those conditions include documented quality management, appropriately qualified personnel, and a justification that no equivalent CE-marked device is available. Competent authorities have signalled that they will scrutinise such exemptions closely, and some have asked institutions to publish a register of the tests they run.

Distributors carry part of the compliance burden as well. They must verify that the manufacturer holds a valid certificate covering the specific assay, that labelling and instructions meet the language requirements of each member state, and that the device is registered in EUDAMED. Several wholesalers have introduced annual supplier re-verification, with certificate expiry dates tracked in the enterprise system, to avoid holding stock that can no longer be lawfully supplied.