Key Amendments to MDR and IVDR: EUDAMED Implementation and Compliance Guidelines

On July 9th, Regulation (EU) 2024/1860 (2024/0021/COD) was published in the Official Journal of the European Union (OJ) making the latest amendments to the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) official.

In our previous blog, we discussed Regulation (EU) 2024/1860, which amends the MDR and IVDR to address key concerns by extending deadlines for legacy IVD devices, requiring advanced notification of device withdrawal. In this blog we'll discuss the gradual EUDAMED implementation, with a focus on compliance and transition requirements for manufacturers.

Current and Projected EUDAMED Module Deployment

EUDAMED's deployment is crucial for the effective implementation of the MDR and IVDR, aiding competent authorities and the Commission in market monitoring and offering significant resource savings for manufacturers by preventing redundant national-level registrations.

As of now, only three EUDAMED modules have been available for voluntary use since December 2020 and October 2021. These include the Actors module, and the UDI/Devices and Notified bodies/Certificates modules. Two additional modules—Market Surveillance and Post-Market Surveillance and Vigilance—are projected for completion in the second half of 2024. The final module, covering Clinical investigations/Performance studies, is expected to be ready by the third quarter of 2026. The findings are derived from the official document, Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024, which amends Regulations (EU) 2017/745 and (EU) 2017/746. 

Gradual Implementation of EUDAMED Modules

According to current MDR rules, mandatory use of EUDAMED is contingent upon the Commission's confirmation of its full functionality. Consequently, the delayed development of the last module delays the mandatory use of all completed modules until at least the fourth quarter of 2027, with transitional periods extending until the second quarter of 2029.

The proposal therefore aims to enable the gradual mandatory implementation of each EUDAMED module once audited and declared functional, potentially beginning as early as the fourth quarter of 2025.

This necessitates amending specific MDR and IVDR transitional provisions to facilitate a seamless transition from multiple national registrations to a single EUDAMED registration. Additionally, timelines for coordinated assessment of clinical investigations and performance studies must be adjusted to reflect the development delays, with voluntary application by Member States leading to mandatory use five years later.

How can Qserve help?

At Qserve, we understand the complexities and challenges posed by the recent amendments to the MDR and IVDR. Our team of experts is ready to assist you in navigating these regulatory changes, ensuring compliance and a smooth transition. We offer comprehensive support in understanding the new deadlines, meeting advanced notification requirements, and preparing for the gradual implementation of EUDAMED modules. Our services include regulatory strategy development, quality management system implementation, and training to keep your team informed and compliant.