Eudamed’s 2-Year Delay: CAMD Executive Group Calls for Interim Solutions
As the European Commission announced a two-year delay of the launch of a new database on medical devices, known as Eudamed, the Competent Authorities for Medical Devices (CAMD) executive group is seeking new solutions to help with the transition ahead of the new May 2022 launch date.In particular, the CAMD executive group is taking issue with the transitional provisions ahead of Eudamed’s full implementation. The new database will contain different modules on actors, unique device identifiers (UDIs), notified bodies and certificates, vigilance, clinical investigations and performance studies and market surveillance. It’s expected to improve the transparency and coordination of information on devices in the EU.
In an open letter, the executive group writes: “With the two years postponement of the whole Eudamed all economic operators (EO) and competent authorities (CA) are facing an enormous challenge, since the alternative is a set of heavily burdensome administrative transitional solutions. Such solutions are not only resource intensive, costly and will take time, but also increase the challenge in providing certainty and ensure consistency in application from the outset.”
The group calls for practical solutions in the short, medium- and long term ahead of the launch of Eudamed, which is at the heart of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
“Together with the Commission, the Member State authorities need to urgently define a joint plan for implementation with clear and consistent approaches to provide for effective implementation and operation of the regulatory system to address identified challenges across the implementation programme with short, medium and long term operational and strategic solutions,” the letter says.
While noting that “many practical issues remain unresolved,” CAMD offered its support to the European Commission and Medical Device Coordination Group (MDCG) “to find legal, effective and operational solutions, which are executable.”
A specific focus should be placed on establishing regular discussions among stakeholders and to identify solutions and to monitor the progress on implementing both regulations, the letter adds.
Meanwhile, on Tuesday, the European Parliament’s Committee on the Environment, Public Health and Food Safety will vote on the adoption of a second corrigendum for MDR and IVDR, potentially giving manufacturers of certain Class I devices an additional four years to comply.
Letter