Regulation 2024/1860 - Amendment of 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 - Main contents

Official Journal

of the European Union

EN

L series

2024/1860

9.7.2024

Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework set out in Council Directives 90/385/EEC (5) and 93/42/EEC (6) and in Directive 98/79/EC of the European Parliament and of the Council (7), such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and require the setting up of the European database on medical devices (Eudamed) to enable transparency and traceability in respect of medical devices and in vitro diagnostic medical devices.

Regulations (EU) 2017/745 and (EU) 2017/746 require the Commission to set up, maintain and manage Eudamed, which includes seven interconnected electronic systems. The development of four electronic systems has been completed and the completion of two further electronic systems is expected 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.

Pursuant to Regulations (EU) 2017/745 and (EU) 2017/746, the obligations and requirements that relate to Eudamed are to apply from a certain date once the Commission has verified the full functionality of Eudamed and published a notice to that effect. The delayed development of the final electronic system therefore holds back the mandatory use of the individual electronic systems that are available.

The use of the electronic systems that are completed or that are about to be completed would largely support the effective and efficient implementation of Regulations (EU) 2017/745 and (EU) 2017/746, decreasing the administrative burden for economic operators. A gradual roll-out of the individual electronic systems of Eudamed should therefore be allowed once their functionality has been verified in accordance with the procedure laid down in Regulation (EU) 2017/745.

Having regard to the gradual roll-out of Eudamed’s electronic systems and to avoid overlapping periods of registration in national databases and in Eudamed, the dates of application of the obligations and requirements that relate to Eudamed and the dates of...