European Commission publishes new Regulation (EU) 2024/1860

The information on this page is mainly intended for manufacturers of medical devices.

What is the purpose of this amendment?

The purpose of Regulation (EU) 2024/1860 is to ensure that sufficient medical devices and medical devices for in vitro diagnostics (IVDs) are available. The reasons for this legislative amendment included concerns regarding the availability of IVDs and the call by Member States during the EU Health Council meeting of 30 November 2024 to accelerate the introduction of EUDAMED. 

Moreover, according to the European Commission, it became clear during the MDR and IVDR transitional period that the supply of certain medical devices and IVDs has been or will be discontinued. In some instances, this interruption of supply may cause severe harm or a risk of severe harm for patients or public health. This applies in situations where no or few alternative devices are available.

What will change?

Regulation (EU) 2024/1860 introduces amendments to three important topics in the MDR and the IVDR:

1. Extension of IVDR transitional periods for existing IVDs

To avoid shortages of specific IVDs, the transitional period has been extended. This applies mainly for devices with a higher risk, such as devices that test for infections when blood or organs are donated or for blood typing in blood transfusions. This will give manufacturers more time to have their products certified under the new rules.

The IVDR categorises IVDs into different risk classes, from class A (low risk) to class D (high risk). An important amendment compared to the previous Directive 98/79/EC (IVDD) is the greater involvement of the 'notified bodies'. Under the IVDD, only 8% of devices were assessed by a notified body. Under the IVDR, this percentage increased to 80%. It is expected that this will lead to a much higher number of certificates under the IVDR than under the IVDD.

The transitional period for class D IVDs was scheduled to end on 26 May 2025. Due to the low number of certificates and applications for class D devices and the lengthy assessment process by the notified body, there was a risk of shortage for many of these devices. The extension of the transitional period reduces this risk.

The changes to the transitional periods for the IVDR are as follows:

Risk class (from low to high risk for individuals and public health)	Old transitional period	New transitional period
class A, brought to market in sterile condition	26 May 2027	31 December 2029
class B	26 May 2027	31 December 2029
class C	26 May 2026	31 December 2028
class D	26 May 2025	31 December 2027

The extension of the transitional period is subject to certain conditions. Only manufacturers who are actively taking measures to comply with the IVDR can benefit from this extension (see Regulation 2024/1860). One of the conditions is that manufacturers must have put in place a quality management system by 26 May 2025 at the latest, pursuant to Article 10(8) of the IVDR. The conditions will ensure that devices brought to market continue to meet high safety standards. The Inspectorate will monitor manufacturers’ compliance with these conditions and their progress throughout the certification process. 

2. Gradual rollout of modules in the European database on medical devices (‘EUDAMED’)

Regulation 2024/1860 includes provisions for a gradual rollout of individual electronic systems (EUDAMED modules) that have already been completed. This amendment replaces the mandatory use of a fully functional EUDAMED and thereby eliminates the postponement of using EUDAMED until the last of the six modules becomes available. The gradual rollout of the modules will accelerate the use of EUDAMED. This is an essential component of an effective implementation of both MDR and IVDR.

Three EUDAMED modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/devices; Notified bodies/certificates). Another two modules (Market surveillance; Vigilance and post-market surveillance) are expected to be ready in Q2 2024. It is not yet known when the final module (Clinical investigations and performance studies) will be delivered.

This legislative change will allow the preliminary use of the finished modules, making implementation more efficient for all stakeholders involved. It will also increase transparency about devices on the EU market.

3. Notification obligation for manufacturers interrupting the supply of critical medical devices and IVDs

This legislatives amendment requires manufacturers and other economic operators to notify the competent authority and healthcare institutions before interrupting the supply of a critical device, whether temporarily or permanently. Such a notification must be made at least six months before the interruption of supply commences. Manufacturers who do not supply devices directly to healthcare institutions or care providers must notify relevant economic operators in the supply chain. These operators can then inform the healthcare institutions.

The Inspectorate will monitor compliance with this notification obligation by manufacturers and other economic operators. This notification obligation gives authorities and healthcare institutions the opportunity to consider risk-mitigating measures. This can increase the health and security of patients.

More information

The Medical Device Coordination Group (MDCG) is drawing up a guidance document for the above three topics in which the interpretation of the legislation is further explained.