MDCG: IVDR-implementation and preparedness plan
The Medical Device Coordination Group MDCG, a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR, more precisely Regulation (EU) 2017/746 on invitro diagnostic medical devices. The plan should serve to set priority actions and monitor their implementation. The IVDR will enter into force on 26 May 2022 with an extended transitional period of five years.
With the overall date of application of the IVDR around the corner, the Regulation 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 samehealth institution, according to Article 5(5) of the IVDR.
This is to allow time to introduce fundamental changes:
- a new device classification system
- greater involvement of notified bodies in conformity assessment
- 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. According to stakeholder estimations, under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80-90%. Currently, only six notified bodies are designated under the IVDR.
Another urgent action the MDCG sees, is the establishing of new guidance on how to apply the IVDR requirements. Such a document is currently under consultation and is planned to be available for industry in the second quarter of 2022.
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.
For a short oversight:
The 2-pages Annex of the implementation plan provides a concise timetable on all actions planned, categorized in topics and their urgency to be addressed.
Source:
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