The Medical Device Coordination Group (MDCG), a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The IVDR will enter into force on 26 May 2022 with an extended transitional period of five years. The plan should serve to set priority actions and monitor their implementation. The Annex of the implementation plan provides summary of actions and a concise timetable on all actions planned, categorized in topics and their urgency to be addressed.
Regulation (EU) 2017/746 foresees staggered transition periods for devices placed on the market under Directive 98/79/EC by class:
- 26 May 2025 for devices that fall in class D under the IVDR;
- 2026 for class C;
- 2027 for class B and A sterile;
- certain provisions for in-house devices (those manufactured and used in the same health institution, according to Article 5(5) of the IVDR.
Transition period will allow time to introduce fundamental changes such as a new device classification system, greater involvement of notified bodies in conformity assessment and new regulatory structures, e.g., the EU reference laboratories and expert panels. With this scenario, plenty of legacy devices, products that are placed on the market under the old Directive 98/79/EC, will be placed on the market. As a priority action, the MDCG plans to develop and endorse a guidance document on IVDR requirements for legacy devices. Still, the risk of shortened availability of devices is not to be underestimated. One concern related to the implementation of the IVDR is the potential risk of shortages and disruption of supply of critical IVDs due to the lack of capacity for certification by notified bodies. Their role is to assess the conformity of medium and high-risk devices against the IVDR requirements before they can be placed on the market. With Eudamed not fully functioning by 26 May 2022, the use of the system will not be mandatory for the time being. It is also considered beneficial to have guidance on harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.
Another urgent action of the MDCG is to establish a new guidance on how to apply the IVDR requirements. Document is currently under consultation and is planned to be available for industry in the second quarter of 2022.