Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic (MDCG 2022-12)
This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed.
The document provides Alternative solutions to submit and/or exchange information (as required under the IVDR) during the absence of EUDAMED.
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) requires the Commission to set up a European database on medical devices (‘Eudamed’). According to paragraph 2 of those Articles, Eudamed will be composed of six different electronic systems (so called ‘modules’), which facilitate the collation and processing of information under the MDR and IVDR regarding the registration of relevant economic operators (actor registration), devices and systems and procedure packs (UDI), notified bodies & certificates, certain aspects of conformity assessment, clinical investigations, performance studies, vigilance and market surveillance as well as post-market surveillance.
On 30 October 2019, the Commission published a notice3 by which it concluded that the full functionality of Eudamed requires the availability and full operation of all six modules, both individually and jointly.
Article 113(3)(f) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the possibility that Eudamed is not fully functional on the date of application of the IVDR (26 May 2022). Accordingly, the obligations and requirements in the IVDR that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) MDR – notice of full functionality of Eudamed. Until Eudamed is fully functional, the IVDR stipulates that the corresponding provisions of Directive 98/79/EC4 shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 113(3)(f) IVDR regarding the exchange of information.
In addition, Article 113(3)(a) IVDR clarifies that Article 26(3) IVDR on the registration of devices, and Article 51(5) IVDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR.