On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation on Medical Devices MDR (EU) 2017/745 and In Vitro Diagnostic Devices (EU) 2017/746 was published in the Official Journal of the European Union. The main changes concern Eudamed and the extension of the transitional periods for compliance with the IVDR Regulation, which will have a significant impact on the industry.
Changes to the Eudamed Implementation Plan
Please note that Eudamed is the European database of Medical Devices, set up and managed by the European Commission, aimed at ensuring transparency and traceability of products; it is a cornerstone of the MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Of the seven electronic systems that make up Eudamed, only four have been developed, with the other two scheduled for completion by the end of 2024. As explained in the new Regulation (EU) 2024/1860, the development of the electronic system for clinical investigations and performance studies has been considerably delayed due to the technical complexity of the prescriptions and workflows to be implemented. Consequently, using Eudamed cannot yet be mandatory, although it can be used, in part, voluntarily (highly advisable option).
Regulation (EU) 2024/1860 introduces a plan for the gradual introduction of Eudamed for devices regulated by one of the two Regulations (MDR and IVDR) and for devices already placed on the market under the previous directives (Legacy Devices).
Only once all modules of Eudamed have been verified and declared functional – by a corresponding notice published in the Official Journal of the European Union – will manufacturers have six months to use the database in compliance with the requirements.
The main objective of these provisions is to facilitate the transition and full implementation of the system, ensuring that manufacturers, Notified Bodies and competent authorities can correctly enter the required data and progressively access the necessary information, without hindering the deployment of safe and effective devices.
How transition periods for IVDR compliance change
As stated in section (7) of Regulation (EU) 2024/1860, despite the increase in the number of Notified Bodies designated under Regulation (EU) 2017/746, the overall capacity is still not sufficient to ensure the certification of the large number of in vitro diagnostic Medical Devices that need to undergo conformity assessment.
To avoid that many safe and critical in-vitro diagnostic Medical Devices, which are essential for the health of patients, are not certified in time, Regulation (EU) 2024/1860 extends the transitional provisions of the IVDR (EU) concerning legacy IVDs (covered by a directive certificate) that require the intervention of a Notified Body in the conformity assessment phase.
Thus, manufacturers of legacy devices will have more time, provided they fulfil three certain conditions:
- have sent an official request for certification for each device to a Notified Body designated according to the IVDR;
- having concluded a contract with a Notified Body for the certification of the device, according to the risk class;
- having implemented a Quality Management System that complies with the requirements of IVDR (EU) 2017/746 (according to the requirements of Article 10(8)) by May 26, 2025.
The length of the transitional period depends on the risk class of the in vitro diagnostic devices in question:
- December 31, 2027, for class D devices;
- December 31, 2028, for class C devices;
- December 31, 2029, for class B devices and class A devices placed on the market under sterile conditions.
For all timelines and specifications: see the complete Regulation.
While extending the transitional periods of legacy IVDs gives manufacturers more time, it is important not to interrupt the long and complex path to compliance.
Obligations in case of interruption or termination of device supply
Regulation (EU) 2024/1860 introduces an obligation for manufacturers to give advance notice of the interruption or termination of the supply of a device that is expected to cause serious harm or risk of serious harm to patients or public health.
For more details on the deadlines and to read the full text of the regulation, please visit the official EU website on EUR-Lex.
Sources:
Regulation (EU) 2024/1860 of the European Parliament and of the Council
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