The European Commission has on 23 January 2024 announced a proposal for an extension to the transition period for the forthcoming In Vitro Diagnostic Medical Devices Regulation (IVDR). The aim is to ensure patient care by improving the availability of these essential healthcare products. In addition, the Commission also proposes measures to enable and accelerate a gradual roll out of EUDAMED, a database that will contain information about all medical devices and in vitro diagnostics (IVDs) placed on the EU market. The mandatory use of finalised parts of EUDAMED will support all key players in the implementation of the regulatory framework and enhance transparency for the public.
The IVDR, applicable since May 2022, aims to renew the EU framework for IVDs to ensure their safety for patients. The latest available data shows that a high number of IVDs currently on the market has not factored in the new rules (nor has been replaced by other devices), meaning that those devices would no longer be available. The number of devices which have not factored in the new rules and are not expected to transition in time is particularly high for high risk IVDs (class D). To improve the availability of such devices, this new proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements.
With the new proposal, the Commission is revising previous transition dates in order to balance the readiness of the sector with high level of public health protection. Under the current provisions, these rules would apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs. The additional time granted with the new proposal to companies depends on the type of device:
- high individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027
- high individual and/or moderate public health risk devices such as cancer tests (class C), would have a transition period until December 2028
- lower risk devices (class B such as pregnancy tests and class A sterile devices such as blood collection tubes), have a transition period until December 2029.
Only ‘legacy devices’, meaning devices covered by a certificate or declaration of conformity issued under the previous legal framework (notably Directive 98/79/EC), may benefit from the extended transition periods if they fulfil the following conditions:
- they continue to comply with the rules in force when they were placed on the market for the first time;
- there are no significant changes in the design or intended purpose of the devices;
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- no later than 26 May 2025, the manufacturer puts in place a quality management system compliant with the IVDR;
- for devices requiring an assessment by a notified body, the manufacturer submits an application to the notified body to transfer the device to the IVD Regulation by 26 May 2025 (class D), 2026 (class C) or 2027 (class B and A sterile IVDs). The manufacturer and the notified body sign a written agreement to proceed with conformity assessment shortly after those dates.
The proposal also requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices, so that member states have more time to take action to ensure patient care.
The Proposal will now be put forward to the European Parliament and Council for adoption. The Commission also noted that it will start working on preparatory work for the targeted evaluation of the medical devices legislation this year.
