Extending the transitional periods for implementation
A considerable number of in vitro diagnostic medical devices (IVDs) currently on the European market do not yet comply with the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). The deadlines for IVDs to comply with the new requirements were looming and causing significant concern for the industry, the pharmaceutical sector and healthcare professionals. Recognising the pressures of recertification and the distinct possibility of IVDs being unavailable for clinical use, the European Commission has proposed further extensions to the IVDR transitional periods.
The Commission proposes the following extensions to the transitional periods:
- December 2027 (previously May 2025) for high risk devices (class D), such as HIV or hepatitis tests;
- December 2028 (previously May 2026) for medium risk devices (class C), such as cancer tests; and
- December 2029 (previously May 2027) for lower risk devices (class B), such as pregnancy tests and sterile blood collection tubes.
This is not the first time the Commission has extended the IVDR transitional periods. In 2021, in the midst of the COVID-19 pandemic and four years after the IVDR entered into force, the deadlines for recertifying or replacing certain medical devices were postponed. The implementation of the IVDR has since continued to be slow and painful. A survey conducted in 2023 by the European Federation of Pharmaceutical Industries and Associations (EFPIA) illustrated concerns that the implementation of the IVDR was impeding clinical trials and blocking access to new medicines for patients. EFPIA recommended delaying the application of the IVDR for all clinical trials that use an IVD. As such, EFPIA will welcome the Commission’s recent proposals to extend the transitional periods.
MedTech Europe has welcomed the new timeframes, noting that they will provide additional leeway for the Commission, the Medical Devices Coordination Group and Notified Bodies to identify and rectify issues that might otherwise prevent manufacturers from failing to meet the implementation deadlines or post-market requirements.
The Commission also tabled proposals:
- to make certain elements of the European Database on Medical Devices (EUDAMED) mandatory; and
- compelling manufacturers to notify proposed discontinuations of certain critical devices.
The mandatory roll-out of EUDAMED in late 2025
The Commission has finally proposed making it mandatory to use of some modules on EUDAMED – the database at the heart of the new MDR and IVDR frameworks. Though many modules remain in development, the Commission wants to start making some modules mandatory.
EUDAMED has six modules:
- actor registration (currently available for voluntary use);
- unique device identification and device registration (currently available for voluntary use);
- notified bodies and certificates (currently available for voluntary use);
- clinical investigations and performance studies (not expected to be completed until Q3 2026);
- post-market surveillance and vigilance (expected to be completed in 2024); and
- market surveillance (expected to be completed in 2024).
The Commission has proposed making the use of some elements of EUDAMED mandatory from late 2025, rather than waiting for the full functionality of the database as originally envisioned.
In an open letter to the Commission, MedTech Europe sets out a number of preconditions that it believes need to be met before any modules of EUDAMED can be made mandatory. These eminently sensible preconditions include that the modules are deemed fully developed, tested audited and ready for practical implementation.
Manufacturer obligation to notify discontinuations
Finally, the Commission proposes a new requirement compelling manufacturers to give prior notice in cases of disruption to the supply of critical medical devices and IVDs. In short, manufacturers will be required to provide information to competent authorities, distributors and healthcare providers at least six months in advance of any discontinuation. While this is a well-intentioned aspiration, it is likely to prove challenging.
The Commission’s proposals will now be put forward to the European Parliament and Council for adoption. If approved, the proposed transitional periods will undoubtedly ease pressure on manufacturers to obtain recertification or replace devices.