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Regulatory Focus™ > News Articles > 2020 > 12 > Eudamed launched with actor registration module live

Eudamed launched with actor registration module live

Posted 01 December 2020 | By Michael Mezher 

Eudamed launched with actor registration module live

The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.
 
“Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medical devices and improve coordination between member states.
 
Last year, the Commission delayed the rollout of Eudamed by two years after concluding that its full functionality relies on the availability of all six of its modules.
 
The remaining five modules are expected to rollout before the database’s May 2022 date of application, with some modules such as the unique device identification (UDI)/device registration and certificates/notified bodies modules expected by May 2021. (RELATED: EC sets timeline for rolling out Eudamed modules, Regulatory Focus 14 May 2020).
 
The Commission has not said when the remaining modules, which pertain to clinical investigations and performance studies, vigilance and market surveillance, will be available, but it has pledged to make all modules available as soon as they are functional.
 
The actor module, which is key to accessing and using Eudamed, allows economic operators to obtain a single registration number (SRN) which provides an EU-wide unique identification. The module also features a searchable database of registered economic operators and competent authorities that allows users to obtain information about the actors that provides information about the entities, such as contact information and identification, and for manufacturers, information about the companies’ responsible persons for regulatory compliance.
 
Having just launched, the economic operators registry is sparsely populated, with information available for only a dozen economic operators. Nearly all national competent authorities have been registered, with information for competent authorities from all EU27 countries, except for Croatia, and Iceland, Liechtenstein and Norway available as of writing.
 
At present, economic operators established in the EU or with authorized representatives in the EU may register. Economic operators based in the UK, Switzerland and Turkey will not be able to register until agreements between those countries and the EU can be reached.
 
Alongside the launch, the Commission released a frequently asked questions document explaining the registration process and addressing issues related to specific roles.
 
European Commission
 

 

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