The European Commission (EC) has recently released updates aimed at ensuring all stakeholders are prepared for the transition to the European Union (EU) In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR).
The EC’s Medical Device Coordination Group (MDCG) has released Q&A guidance on how the certification of class D in vitro diagnostics will be completed during the IVDR transition period. Class D IVDs are the highest risk devices and are subject to more stringent requirements than class A-C devices, and this includes being reviewed by an expert panel and/or testing in an EU references laboratory (EURL). Whilst IVD expert panels have been set up, EURLs have not been and consequently several questions relate to EURLs.
The guidance stipulates that if there is no EURL designated for a particular device, then the expert panel should provide its views within 60 days. In this scenario, notified bodies may still accept applications and issue certificates for class D devices. Furthermore, this certificate will remain valid until its expiry date. However, manufacturers and notified bodies should follow the EURL-related provisions for sample and batch testing from the time that the EURL becomes operational. Guidance on the expert panel details when their consultation is required, how the notified body interacts with the panel, and how these interactions are impacted by situations in which the IVD expert panel is not yet operational.
In addition, the EC has a separate document detailing its rolling implementation plan for both the MDR and IVDR. It outlines the essential actions and initiatives needed to ensure a smooth transition to the incoming regulations, and is updated on a quarterly basis. Many of these updates follow on from the IVD Q&A guidance and provide expected dates for actions related to EURL establishment and the common specifications for class D IVDS. Other updates concern the expected implementation dates of certain MDR related provisions such as Eudamed’s date of application and common specifications for devices without a medical purpose (listed in MDR Annex XVI).