The actor module for EUDAMED was released live on 01 December 2020. In advance of this date, the European Commission (EC) provided the medical device industry with a 60 page Actor Registration Guide illustrating the required data entry methodology. Since December, the EC and Medical Device Coordination Group (MDCG) have issued various FAQs, position papers and infographics to further explain the functionality and define terms necessary for those economic operators obligated to upload data into the EUDAMED system.

Seven months after the actor module deployment (and 18 months following the original date of full EUDAMED deployment) the medical device industry remains confused. Our friends at the MDCG have posted guidance MDCG 2021-13 rev.1 July 2021 in the effort to deliver additional clarification on the obligations and rules for the registration in EUDAMED, in this instance, for the “other” actors.

Actor ID: is the identifier issued to all actors registered in EUDAMED for their identification in the system. It will be automatically generated by EUDAMED and issued once the registration request is approved by the relevant competent authority.

SRN: is the Single Registration Number that is issued through EUDAMED to manufacturers, authorised representatives and importers by the competent authority.

The actor registration request for any manufacturer, authorised representative, importer or a system/procedure pack producer must be verified and approved by a competent authority.

It must be noted, if an actor entity subsequently takes on the role and obligations of a manufacturer, Authorised Representative or importer of a non-custom-made MDR device, the Actor ID will then be considered as an SRN.

System and Procedure Pack Producers (SPPP)

Before placing a system or procedure pack on the market, the legal person responsible has an obligation to assign a Basic UDI-DI to be provided to the UDI database. In order to fulfil this obligation and before placing the system or procedure pack on the market, the SPPP must be registered in EUDAMED (deadline 6 months after notice of full EUDAMED functionality). Registered SPPPs are assigned an Actor ID.

The continued ambiguity, for what should be a straight-forward process data entry for the actor registration module, does not bode well for a smooth roll out for the remaining EUDAMED modules.

We trust many more clarification documents for EUDAMED and MDR compliance will be forthcoming from the EC Commission and Medical Device Coordination Group to support industry’s drive to retain and obtain the marketing status of life-enhancing devices for the European population.

Please feel free to contact me if you have any additional questions – I am available to help

KimYoung@instem.com

K Young

References

MDCG 2021-13 rev.1

MDCG Endorsed Documents and Guidance

Actor Roles Infographic

Actor Module FAQs

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