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Regulatory Focus™ > News Articles > 2021 > 3 > MDCG issues guidance on Eudamed alternatives

MDCG issues guidance on Eudamed alternatives

Posted 01 March 2021 | By Michael Mezher 

MDCG issues guidance on Eudamed alternatives

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.
 
While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, such as the unique device identification (UDI)/device registration and certificates/notified bodies modules are expected by May 2021. (RELATED: Eudamed launched with actor registration module live, Regulatory Focus 1 December 2020).
 
With the postponed date of application of MDR set for 26 May 2021, some functions of Eudamed may not be fully functional by the date of application. Under Article 123(3)(d) of MDR, the “obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after” the Commission publishes a notice declaring Eudamed to be fully functional in the Official Journal of the European Union.
 
“Until Eudamed is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(3)(d) regarding the exchange of information,” MDCG writes. Article 123(3)(e) also specifies that requirements obligations and requirements set out in Articles 29(4) and Article 56(5) of MDR apply 24 months after the notice.
 
Accordingly, the MDCG guidance breaks down the Eudamed-related provisions of MDR and provides alternative solutions to fulfill the requirements for submitting or exchanging information.
 
“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 Directives 90/385/EEC and 93/42/EEC,” MDCG writes.
 
Specific guidance is provided for administrative practices and alternative technical solutions for Eudamed-related obligations and requirements under MDR Articles 29, 31-33, 40, 42, 43, 46, 53-56, 70, 73-78, 80, 86- 89, 90, 93, 95, 97-99 and 120.
 
MDCG

 

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