The European regulations governing in vitro diagnostic devices have recently been updated, and enter into force on 26 May 2022 (some exceptions are noted in the slide deck). This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.
Some areas of interest include:
- creation of a new European database on medical devices (Eudamed) that will integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance.
- new requirements for a Unique Device Identification system (‘UDI system’) to allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices.
- The position of notified bodies vis-à-vis manufacturers is being strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification.
- Establishment of a Medical Device Coordination Group (MDCG)