European Commission issues Q&A on phased implementation of Eudamed
The European Commission last week issued guidance addressing how manufacturers should prepare for the gradual roll-out of Eudamed called for in recent amendments to the Medical Device Regulations (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).The document, which is in a question-and-answer format, is intended to address the practical realities of Eudamed’s phased implementation. The European Parliament adopted this amendment as well as other changes to MDR and IVDR in April 2024 (RELATED: European Parliament votes to delay IVDR transition, speed EUDAMED adoption, Regulatory Focus 25 April 2024).
Another amendment under MDR and IVDR requires manufacturers to report potential shortages, which was the topic of a Q&A in October. (RELATED: European Commission Q&A details shortage reporting requirements under MDR, IVDR, Regulatory Focus 30 October 2024).
The Eudamed system is a centralized database storing information and includes six modules. It covers actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, market surveillance, post-market surveillance, and clinical investigations and performance studies. It was launched in late 2020. (RELATED: Eudamed launched with actor registration module live, Regulatory Focus 1 December 2020).
The Commission states that under the new wording of Article 123(3)(d) of MDR and Article 113(3)(e) of IVDR, “the obligations and requirements that relate to a certain module of Eudamed will become applicable 6 months after the publication” of a notice in the Official Journal confirming the functionality of a module.
The Commission further stated that the amendment to Article 34 of MDR “enables the gradual implementation of Eudamed by a roll-out of individual modules once each individual module is audited and a Commission notice confirming the functionality of the module is published.” It added that the steps to confirm the functionality of a module have not been changed, and that independent audits will still be needed to verify that the module meets functional specifications.
The guidance noted that the following economic operators will need to register in the actor module: system or procedure pack operators (SPPPs), manufacturers who exclusively place custom-made devices on the market, manufacturers who exclusively place class III custom-made implantable devices on the market, and sponsors of clinical investigations.
Distributors are not required to register in Eudamed but may be required to do so in accordance with Member State requirements.
The Commission further noted that legacy and regulation devices where individual sales units are no longer placed on the market do not need to be registered in Eudamed when the UDI module becomes mandatory. This module has been available for voluntary use since October 2021.
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