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Regulatory Focus™ > News Articles > 2020 > 5 > EC sets timeline for rolling out Eudamed modules

EC sets timeline for rolling out Eudamed modules

Posted 14 May 2020 | By Michael Mezher 

EC sets timeline for rolling out Eudamed modules

The European Commission will begin making some Eudamed modules available next year, including the actor registration module originally anticipated this month, according to an email to members of the Eudamed working groups.
 
The message was circulated after the one-year delay of the Medical Devices Regulation (MDR) was adopted by the European Council in late April and follows the Commission’s decision to delay the application of Eudamed by two years to May 2022. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Eudamed’s 2-year delay: CAMD executive group calls for interim solutions, Regulatory Focus 2 December 2019).
 
“The Commission, in agreement with the [Medical Device Coordination Group] MDCG, has pledged to make available the different modules on a gradual basis as soon as they are functional,” the Commission’s SANTE Eudamed team said in the email.
 
While “the development of Eudamed is ongoing,” and the first actor module will be ready this month, the Commission noted that “the deployment of the actor registration module will not take place in May [2020] as originally planned due to the postponed application date.”
 
Instead, the Commission said the actor registration module will be made available “at the latest by March 2021.”
 
Afterwards, the modules for unique device identification (UDI)/device registration and certificates/notified bodies come online “as soon as functional,” which the Commission said could be done by May 2021.
 
The release of the modules prior to the May 2022 date of application will give medical device makers and notified bodies more time to familiarize themselves with the database.
 
The email did not give a timeline for making other modules available, such as those for clinical investigations and market surveillance.

Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD and RAPS board member, told Focus that “timely and predictable availability of Eudamed modules is of vital importance. Eudamed will be the ‘backbone’ for communication and information exchange in the EU medical device regulatory system,” under MDR and the In Vitro Diagnostic Regulation.

“This is of course also applicable to notified bodies, as a lot of our internal processes and communication with manufacturers and authorities are connected to or depending on Eudamed,” she said.

Hoekstra-van den Bosch also said it would be ideal if the Commission “could utilize the time till the new MDR date of application of 26 May 2021 to build a properly functioning Eudamed, thus avoiding the need for all stakeholders, including notified bodies, to invest lots of effort in interim solutions.”

Editor’s note: this article was updated to include comment from Sabina Hoekstra-van den Bosch.

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