SVP Global Regulatory and Quality
On January 23, 2024, the European Commission posted a Proposal for a further extension to companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. Specifically, this Proposal suggests granting a new extended timeline for companies with IVD products already on market in the EU depending on the risk classification of the device. There will be a shorter transition period for high risk IVDs and longer periods for medium and lower risk IVDs, as follows:
- 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.
The Proposal is not final and will now be put forward to the European Parliament and Council.
If adopted, 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. And, as with the currently in effect transitional provisions, only if they continue to comply with the rules in force when they were placed on the market for the first time and if there are no significant changes in the design or intended purpose of the devices;
However, this Proposal introduces the following additional conditions in order for legacy devices to benefit from the extended timelines:
- 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 IVD Regulation;
- 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 above new proposed requirements may mean that those with class C or class B and class A (sterile) IVDs have less time in which to put in place an IVDR-compliant quality management system
Thus, while the Proposal buys those with CE-marked IVDs already on market more time, the above new proposed requirements may mean that those with class C or class B and class A (sterile) IVDs have less time in which to put in place an IVDR-compliant quality management system and less time to submit an application to their Notified Body to transfer legacy devices to the IVD Regulation by 26 May 2025 (class D), 2026 (class C) or 2027 (class B and A sterile IVDs). This last condition aims to ensure that only devices that the manufacturer intends to transition to the IVDR will benefit from the extended transition period.
For companion diagnostic (CDx) companies, non-CE marked CDx will need to move forward as planned. However, the extended timelines could alleviate issues with Notified Body capacity if they strive to get their IVDs through the conformity assessment process ahead of the revised transitional provisions, keeping in mind the shorter timeline for Class D devices.
Additionally, not providing immediate relief, the Proposal also calls for the timelines for the application of the coordinated assessment of performance studies (IVDR Article 74) to be adapted. Keeping the approach provided for in the IVDR, the Proposal indicates the coordinated assessment procedure for performance studies should first be applied by Member States on an ‘opt-in’ basis but five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. If adopted, these changes should ultimately aid in offsetting the delay in the development of the Eudamed module for performance studies. Those companies involved in combined studies (i.e., those a clinical trial of a medical product in parallel with a performance study of an in vitro diagnostic) may reap the greatest benefit.
We are also keeping abreast of the developments of the COMBINE project, launched in June 2023. The Member State’s competent authorities for clinical trials and medical devices and the European Commission initiated the COMBINE project to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions to these challenges.
The Proposal also calls for mandatory use of some European database on medical devices (Eudamed) modules that are already finalized, and new obligation for manufacturers to give prior notice in case of disruption of supply of certain IVDs.
The EU Commission’s press release and links for associated documents can be reviewed here: https://lnkd.in/g_Es65ku
The full Proposal can be viewed here: https://lnkd.in/gA7wA4JS
The EU Commission’s overview of the COMBINE project can be viewed here: https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies_en
How We Can Help
Beaufort’s team of experts are currently helping companies navigate the continually evolving IVDR landscape. We have on-going projects focusing on QMS implementation, Technical Documentation preparation and review and navigation of the current processes for preparation and review of National requirements for companion diagnostic clinical performance study documentation and Competent Authority/EC review.
Contact us today for a consultation.