MDCG offers guidance on Eudamed workarounds for IVDR
The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday issued guidance on administrative practices and alternative technical solutions on the application of certain In Vitro Diagnostic Regulation (IVDR) provisions in the absence of a fully functional Eudamed system.The guidance comes just two months after IVDR went into effect and follows a similar guidance on Eudamed administrative practices and alternative solutions under the Medical Device Regulation (MDR) that was issued last year. (RELATED: IVDR implementation day overshadowed by lack of notified bodies, risks to patients, Regulatory Focus 26 May 2022; MDCG issues guidance on Eudamed alternatives, Regulatory Focus 1 March 2021)
Both regulations call for the establishment of a European database for medical devices which will consist of six modules, three of which are presently available for use on a voluntary basis. Those modules include the actor registration, UDI/device registration, and notified bodies/certificates module.
However, the requirements related to Eudamed are not applicable until after the database is declared fully functional. The European Commission has said that it intends to make the remaining three modules for vigilance, clinical investigation/performance studies and market surveillance at the time the system is declared fully functional.
“The mandatory use of the system will start when the entire Eudamed system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations,” the Commission states.
MDCG also notes that the provisions of IVDR related to the registration of devices under Article 26(3) and registration certificates under Article 51(5) do not apply until two years after the notice is published in the Official Journal.
Specific guidance is provided for administrative practices and alternative technical solutions for Eudamed-related obligations and requirements under IVDR Articles 26, 28-30, 36, 38-40, 42, 49-51, 66, 69-74, 76, 81, 83-85, 88, 90, 92-94, 110. For each article, the guidance explains the provisions under IVDR related to Eudamed, and the alternative solutions diagnostic makers may employ in lieu of a fully functional Eudamed.
“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,” MDCG writes.
MDCG
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