European Commission just announced the availability of the EUDAMED Actor Registration module for voluntary, production use by Member States and Economic Operators.

The EUDAMED database is a key enabling feature (central database and collaboration tool) of the new Medical Device and In Vitro Diagnostic Device Regulations (MDR and IVDR respectively).  Its Actor Registration module will need to be used by Economic Operators across Europe to obtain a Single Registration Number (SRN).

Economic Operators include manufacturers, authorized representatives, importers and system/procedure pack producers in the field of Medical Devices and In Vitro Diagnostic devices.  Distributors will continue to be managed by the National Competent Authority and if the local law requires, in the national databases.

The advantage of getting a Single Registration Number (SRN) early is to include it in relevant regulatory documentation (such as Declaration of Conformity, Technical Documentation, Conformity Certificates issued by a Notified Bodies, and Certificate of Free Sale) without the need to update them at a later stage as the SRN will remain unique and constant across all of Europe.

SRN will also enable the Actor to use future EUDAMED modules (e.g. for UDI/Device registration, Vigilance and Post-Market Surveillance reporting, and Clinical investigations).

• As of 1^st December 2020, economic operators in the field of Medical Devices and IVDs can begin using the Actor Registration module. The Competent Authorities of EU Member States, where the actor has its registered place of business, may accept this registration to fulfil the MDR/IVDR actor registration obligations, in lieu of registration in their national database – in accordance with the local national requirements.  France, Sweden and Belgium have already confirmed their acceptance of this arrangement.

• Please note that the registration is required per role. For example, if a legal entity acts as the authorized representative as well as the importer, the same legal entity will need to register twice: once as an EC REP and separately as an Importer.

• Distributor registration is out of the scope for MDR/IVDR and therefore, EUDAMED is not applicable. They continue to be managed by the National Competent Authority and if the local law requires, they need to be registered in the national database as well.  Distributors will not get an SRN (See MDR Art 31; IVDR Art 28 for specific regulatory requirements).

• The Single Registration Number (SRN) required by the MDR and IVDR can only be obtained through the EUDAMED Actor Registration module after the economic operator registration has been validated by the responsible National Competent Authority. (Please note that there is no timeline indicated in the MDR/IVDR for Competent Authorities to complete the validation of the submitted registration), but early empirical experience suggests that it will be a relatively quick process (hours to days).

 

Registration in the EUDAMED Actor Registration module is not legally binding as per MDR/IVDR until six months after the launch of a fully functional EUDAMED system complete with ALL six modules (planned for May 2022 unless national law obliges the use of EUDAMED).

For more information, read the EC’s EUDAMED Actor Module FAQs.