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MDCG outlines Eudamed obligations for legacy, custom devices

Posted 28 June 2021 | By Michael Mezher 

MDCG outlines Eudamed obligations for legacy, custom devices

The European Commission’s Medical Device Coordination Group (MDCG) last week released a questions and answers guidance detailing how Eudamed rules apply to actors not subject to registration requirements under the medical devices regulation (MDR) and in vitro diagnostic regulation (IVDR), including manufacturers of custom-made and legacy devices.
 
The guidance also clarifies situations in which an Actor ID is issued instead of a single registration number (SRN). An Actor ID is issued to all actors in Eudamed for their identification in the system and is automatically generated once the registration is approved by the relevant competent authority. An SRN is issued through Eudamed specifically to manufacturers, authorized representatives and importers by a competent authority.
 
Under MDR and IVDR, actors other than manufacturers, authorized representatives and importers are required to register as actors in Eudamed under certain circumstances. Registration procedures are expected to be laid out in an upcoming Commission Implementing Regulation.
 
The guidance explains that when an actor not subject to the obligations of Article 31 of MDR or Article 28 of IVDR submits an actor registration request to report a serious incident or field safety corrective action (FSCA) for the first time, they should immediately notify the relevant authorities outside Eudamed. The related registration request should also specify that the request was triggered by the need to report a serious incident or an FSCA.
 
Manufacturers who only produce custom-made devices are exempted from needing to register before placing their devices on the market. However, the guidance explains that manufacturers of custom-made devices will need to register as actors in Eudamed to meet certain obligations under MDR, including the obligation to enter information on class III custom-made implantable devices and to report serious incidents, field safety corrective actions, filed safety notices and any trends of non-serious incidents for their custom-made devices.
 
Those registration requirements also apply to non-EU manufacturers of only custom-made devices, as well as to their authorized representatives.
 
Manufacturers and authorized representatives of only custom-made devices will only be assigned an Actor ID that is not an SRN.
 
Similarly, manufacturers of only legacy devices must register as actors in Eudamed within six months of the date of publication of the notice under Article 34(3) of MDR announcing the functionality of Eudamed. This requirement applies to non-EU manufacturers and their authorized representatives, and such actors will be assigned an Actor ID that is not an SRN. (RELATED: European Commission explains management of legacy devices in Eudamed, Regulatory Focus 12 February 2021)
 
Manufacturers of “old” devices, which include devices placed on the market prior to, or according to, the medical device and in vitro diagnostic directives, will need to register for Eudamed to submit reports of serious incidents or FSCAs. This obligation is applicable to non-EU manufacturers and authorized representatives as well. However, inactive manufacturers and authorized representatives of old devices are not subject to Eudamed registration requirements.
 
The guidance also explains that system and procedure pack producers (SPPPs) must register as an actor within six months of the notice announcing the functionality of Eudamed, as they are obligated to assign a basic unique device identification-device identifier (UDI-DI) to be provided to the UDI database.
 
Lastly, the guidance clarifies when an Actor ID can be considered as an SRN pursuant to Article 31 of MDR and Article 28 of IVDR. “The Actor ID will only be considered as a SRN when it will be issued to a manufacturer or authorised representative or importer of MDR non-custom-made devices and/or of IVDR devices.”
 
Guidance

 

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Tags: Eudamed, IVDR, MDR

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