Regulation (EU) 2024/1860- the latest changes to MDR and IVDR

On 9 July 2024, regulation (EU) 2024/1860 was published in the Official Journal of the EU, amending regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply and transitional provisions for certain in vitro diagnostic medical devices.

What was the purpose of the next changes?

Regulation (EU) 2024/1860 introduces significant changes to previous regulations on medical devices and in vitro diagnostic medical devices, with the aim of ensuring patient safety, a high level of public health protection and avoiding potential market disruption.

Gradual roll-out of Eudamed

Eudamed is a European medical device database consisting of interconnected electronic systems. Four electronic systems have been completed so far and two more are expected to be completed in 2024. However, the development of the electronic system on clinical investigations and performance studies has been significantly delayed due to the technical complexity of the requirements and workflows to be implemented.

After the entry into force of regulation (EU) 2024/1860, the EUDAMED database will be declared functional module by module. This changes the original assumption that EUDAMED cannot become mandatory until all modules are fully functional. This means that the use of modules that are already available will become mandatory without having to wait for all seven modules to be ready and implemented.

The individual electronic systems of the Eudamed database will be gradually implemented after their r functionality has been verified – each module will undergo an independent audit, and then a notification will be published in the Official Journal of the EU (OJEU) stating that the module is functional and meets the required specifications.

The updated timeline illustrating the gradual roll-out plan for the Eudamed modules can be viewed on the European Commission website (last updated 10 July 2024) https://health.ec.europa.eu/latest-updates/updated-timeline-current-planning-gradual-roll-out-and-modules-functionality-view-2024-07-10_en

Information about interruption or discontinuation of supply of devices

Due to the potential harm to patients in the presence of shortages of critical devices, an amendment has been introduced to Article 10 of regulations (EU) 2017/745 and (EU) 2017/746, which requires the manufacturers to report an interruption or a discontinuation of the supply of a device, other than a custom-made device. The manufacturer shall inform the competent authority of the Member State in which the manufacturer or its authorised representative is established of the anticipated interruption or discontinuation of the supply, at least six months before the expected anticipated interruption or discontinuation, together with the reasons for the interruption or discontinuation. The manufacturer is also obliged to provide such information to economic operators, health institutions and healthcare professionals to whom it directly supply the device.  Additionally, economic operators such as importers and distributors are obliged to notify all other economic operators, health institutions and healthcare professionals to whom they directly supply the device about any anticipated interruption or discontinuation.

The competent authority that has received information about an anticipated interruption or a discontinuation of the supply, inform the competent authorities of the other Member States and the European Commission.

The obligation to inform about the interruption or a discontinuation of the supply of a device will apply from 10 January 2025.

Extension of transitional periods for in vitro diagnostic medical devices

Despite the increase in the number of notified bodies designated in accordance with regulation (EU) 2017/746, the overall capacity of notified bodies is still insufficient to ensure the certification of the large number of in vitro diagnostic medical devices that require conformity assessment involving a notified body.

In order to avoid a situation where many safe and critical in vitro diagnostic medical devices, essential for the diagnosis and treatment of patients, would not obtain certificates of conformity in accordance with regulation (EU) 2017/746  before the end of the transitional periods, regulation (EU) 2024/1860 extends the transitional periods for devices covered by certificates in accordance with directive 98/79/EC. The new transitional periods also cover devices that are to undergo conformity assessment for the first time with the participation of a notified body under regulation (EU) 2017/746.

The extension of the transitional periods applies to:

– Devices with a certificate issued in accordance with directive 98/79/EC, such devices may be placed on the market or put into service until 31 December 2027

– Devices for which the conformity assessment procedure did not require the involvement of a notified body, the declaration of conformity was drawn up before 26 May 2022 and for which the conformity assessment procedure based on the regulation (EU) 2017/746 requires the involvement of a notified body – such devices may be placed on the market or put into service until the following dates:

• 31 December 2027 for class D devices;
• 31 December 2028 for class C devices;
• 31 December 2029 for class B devices and for class A in sterile condition.

Manufacturers of legacy devices will be able to benefit from extended transitional periods only if they meet the following conditions:

1. the devices continue to meet the requirements of directive 98/79/EC;
2. there are no significant changes in the design and intended purpose;
3. the devices do not pose an unacceptable risks to the health or safety of patients, users or other persons or to other aspects of public health protection;
4. the manufacturer has introduced a quality management system in accordance with Article 10 of the regulation (EU) 2017/746 no later than 26 May 2025;
5. the manufacturer or the authorised representative has lodged a formal application to a notified body for a conformity assessment of the device or in respect of a device intended to substitute that device, no later than:

• 26 May 2025 for class D devices;
• 26 May 2026 for class C devices;
• 26 May 2027 for class B devices and class A devices in sterile condition;

6. the notified body and the manufacturer have signed a written agreement no later than:

• 26 September 2025 for class D devices;
• 26 September 2026 for class C devices;
• 26 September 2027 for class B devices and class A devices in sterile condition.

Depending on the risk class of the in vitro diagnostic medical device, the above conditions can be presented as follows:

IVDR classification	Implemented OMS according to IVDR	Lodged Application with Notified Body	Written Agreement with Notified Body	End of the transition period
Class D	26 May 2025	26 May 2025	26 September 2025	31 December 2027
Class C	26 May 2025	26 May 2026	26 September 2026	31 December 2028
Class B	26 May 2025	26 May 2027	26 September 2027	31 December 2029
Class A (sterile)	26 May 2025	26 May 2027	26 September 2027	31 December 2029

Conclusion

Regulation (EU) 2024/1860 was adopted due to circumstances related to the imminent risk of shortages of in vitro diagnostic medical devices, which could trigger a public health crisis. An additional factor was the significant delay in the development of the electronic system on clinical investigations and performance studies in the Eudamed database.

Although regulation (EU) 2024/1860 extends the transition periods for in vitro diagnostic medical devices, it should be emphasized that manufacturers should not delay compliance with IVDR requirements. The first important deadline for all manufacturers is 26 May 2025 – the time by which manufacturers should have a QMS in place to take advantage of the transition periods. The additional time should also be used to plan and collect additional clinical data obtained from performance studies and post-marketing performance follow-up studies.

For obligations related to the EUDAMED database and reporting on interruption or discontinuation of supply of certain devices, manufacturers should plan and establish processes to complete data in the EUDAMED database and identify interruptions in the supply chain.

Find out more: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401860

In order to facilitate the application of regulation (EU) 2024/1860, a document in the form of questions and answers on practical aspects related to the extension of the regulation (EU) 2017/746 transition periods has been published. The document can be viewed here: https://health.ec.europa.eu/document/download/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf