Harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
The Medical Device Coordination Group has released a revision of the guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.
This is especially helpful since the MDR fully applies by the 26th May, implying that the obligations regarding EUDAMED need to be met.
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) requires the Commission to set up a European database on medical devices (‘EUDAMED’).
The same article states that Eudamed will be composed of six different electronic systems (modules), which facilitate the collation and processing of information under the MDR 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, vigilance and market surveillance as well as post-market surveillance.
On 30 October 2019, the Commission published a notice by which it concluded that the full functionality of EUDAMED requires the availability and full operation of all six modules, both individually and jointly. The notice foresees the launch of EUDAMED for May 2022, which correlates with the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices3 (IVDR).
Article 123(d) MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021). Accordingly, the obligations and requirements in the MDR 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 – notice of full functionality of Eudamed. Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(d) regarding the exchange of information.
In addition, Article 123(e) MDR clarifies that Article 29 MDR on the registration of devices, and Article 56 MDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34 MDR.
This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.
The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned.
This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of the Directives. This guidance takes into account the decision of the MDCG that the Commission makes available to Member States each EUDAMED module as soon as it is operational. This approach also has an impact on the means by which relevant information collected under the MDR will be made available to the public, which shall take place on a gradual basis.
The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the requirements under the MDR, including those contained in the provisions referred to in Article 123 letters (d) and (e) MDR.
Whenever this guidance makes reference to CircaBC as alternative solution, the Commission and other relevant parties should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate.
Parties should also take note of the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
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