More on European Proposal to Delay Compliance for Legacy IVDs

By Annette Van Raamsdonk

The European Commission (EC) proposed to extend the transitional provisions for certain IVD devices. This decision comes after the extended transitional provisions for certain medical devices that came with the adoption of Regulation (EU) 2023/607 were announced January 23.

This was after many letters and statements from stakeholders, in which concerns were raised about the shortages of IVDs that might occur if no action was taken. The EC acknowledged the pivotal role of these devices within healthcare: “It is estimated that around 70 percent of clinical decisions are made using in vitro diagnostic medical devices.”

What can IVD manufacturers expect?

Currently, high-risk IVDs (Class D) would need to transition to the Regulation on In Vitro Diagnostic Medical Devices (2017/747, IVDR) May 26, 2025. Class A sterile, Class B and C IVDs should be transitioned to IVDR compliance by May 26, 2027. The proposal amends Article 110 IVDR and grants additional time for manufacturers of legacy IVDs.

The transitional provisions would be amended as follows:

• Legacy IVDs Class D (IVDR) must comply by December 31, 2027.
• Legacy IVDs Class C (IVDR) must comply by December 31, 2028.
• Legacy IVDs Class B and Class A sterile (IVDR) must comply by  December 31, 2029.

Certain conditions will need to be met by the manufacturer to be eligible for the extended transitional provisions. These conditions are similar to those for medical devices under Regulation (EU) 2023/607. Amongst others, the manufacturer will need to have applied to a Notified Body (NB) designated for the IVDR for the devices, no later than May 26, two years before the compliance date, depending on the risk class of the IVD. A signed written agreement with the NB needs to be in place by September 26 two years before the compliance date, depending on the risk class of the IVD.

Depending upon IVD risk class, the compliance date is:

• Legacy IVDs Class D (IVDR) application by May 26, 2025 and agreement September 26, 2025
• Legacy IVDs Class C (IVDR) application by May 26, 2026 and agreement September 26, 2026
• Legacy IVDs Class B and Class A sterile (IVDR) application by 26 May 2027 and agreement 26 September 2027

Concluding remarks

Once the proposal is reviewed and approved by Parliament and Council and is published in the Official Journal of the European Union (OJEU), manufacturers of legacy IVDs can benefit from the extended transitional provisions.

However, this does not mean manufacturers can pause their activity. Under the IVDR, over 80 percent of IVDs are subject to NB scrutiny. This is compared to 8 percent of IVDs under the directive. Based on the latest NB survey (December 2023), only 677 certificates have been issued across all risk classes of IVDs. There seems to be little progress in the transition of IVDs to IVDR compliance.

Manufacturers will need to start contacting NBs to ensure an agreement is in place in time, as well as a Quality Management System (QMS) in accordance with Article 10(8) IVDR. This is with the aim of health care continuity.

Emergo by UL will continue to monitor further developments on this amendment.