Article 33 of the MDR and Article 30 of the IVDR require the Commission to set up a European database on medical devices (“Eudamed”). The IVDR stipulates that the corresponding provisions of the IVDD 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 until Eudamed is fully functional.
MDCG 2020-12 addresses in particular cases, where the exchange of information would be difficult, or it even being possible to achieve, based on the corresponding provisions of the IVDD. The proposed practices and solutions set out in the guidance yet do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.
Attachment: MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)