Legislation Published to Delay Compliance for Legacy IVDs and EUDAMED Rollout

By Beth Pugh, Ken Pilgrim and Evangeline Loh

Additional legislation officially amending the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/745, IVDR) was published as Regulation 2024/1860 on June 13.

Background on the European Commission Proposal, January

The European Commission (EC) announced (January 23) a proposal (COM(2024)43/ 5712/24) to delay compliance of legacy IVD devices and for EUDAMED to be rolled out by modules completed.

Analogous to Regulation (EU) 2023/607 for legacy medical devices, the amending regulation extends the time legacy IVDs need to be compliant with the IVDR, under certain conditions, including an application with a notified body designated to the IVDR and an agreement with the notified body for the IVD in question, two years before the deadline (by new IVDR class) May 26 and September 26, respectively.

Further, EUDAMED modules will be released once verified and published in the Official Journal of the European Union (OJEU), with the first set expected in Q4 2025. Also, economic operators would be required to notify the member state's competent authority where the manufacturer (or the authorized representative) is located in the event of expected device or IVD shortages beginning January 10, 2025. The notification and reason for the interruption are expected to be provided at least six months before the anticipated interruption, other than in exceptional cases.

First reading with Council and European Parliament

The EC proposal proceeded rapidly through the Council. The Working Party on Pharmaceuticals and Medical Devices convened seven days later (January 30). By early February, “no modifications to the text proposed by the Commission” were reported  (Document ST_6067_2024_INIT). The Committee of Permanent Representatives (Coreper) agreed to the text in mid-February (February 14).

The EC proposal was assigned to the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI).

Both the Council and European Parliament publicized (February 21) the compromise agreement as formally adopted pending legal-linguistic revision. A European Parliament brief reported the events that transpired as: “The Coreper chair informed the ENVI committee chair on  February 21, 2024, that, should Parliament adopt its position at first reading in the exact form of the proposal, the Council would approve Parliament's position, and the act would be adopted in the wording that corresponds to the European Parliament position.”

Parliament approved the proposal in an April 11 plenary session through Rule 163, urgent procedure.

In a press release (April 25), the Council lauded the European Parliament’s adoption of the measures. Council formally adopted the measures (May 30).

Official publication

Council formally adopted the amending regulation, promulgated as Regulation 2024/1860. The legislation enters into force on July 9, the publication date in OJEU.

The EC will also release a frequently asked questions document shortly. As well as accompanying guidance documents.  

Concluding remarks

Similar to Regulation 2023/607, Regulation 2024/1860 progressed through the legislative process swiftly. This is in stark contrast to both the MDR and IVDR, which were published in 2017 after years of contentious debate and readings amongst the EC, Council and the European Parliament.  

While this affords manufacturers of IVD legacy devices additional time, it is important for manufacturers to diligently continue with their compliance journey. There are impending deadlines for applications with a notified body designated to the IVDR, as well as dates by which an agreement must be signed. Additionally, the legacy IVD must continue to comply with Article 110 with “no significant changes in the design and intended purpose” for the legacy device(s).

We at Emergo by UL will continue to report on developments with the IVDR, and we remain available to assist on a consulting bas