IVDR Update related to EUDAMED
Article 33 of Regulation (EU) 2017/745 on medical devices1 (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 requires the Commission to set up a European database on medical devices (‘Eudamed’).
The guidance 2022-12 recalls various factors related to the requirement of all 6 modules to be functional and quotes Article 113(3)(f) from the EU IVD Regulation [IVDR] which 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.
This document provides guidance to Member States and other relevant parties on the application of certain IVDR 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 IVDR 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 Directive 98/79/EC.
The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR. 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.
For complete understanding, we strongly recommend the use of the guidance document which is accessible from here.
Looking for Regulatory Support?
Med-Di-Dia is here to be your Regulatory Risk Partner for Medical Devices, Diagnostics and Digital Health!
Drop us an email at email@example.com