You may find that Guidance
MDCG 2021-13 rev. 1 provides the answers here. This is what it says about procedure pack assemblers and EUDAMED:
"6. Do system and procedure pack producers (SPPP) have to register as actors in EUDAMED?According to Article 29 (2) MDR, before placing a system or procedure pack on the market, the natural or legal person responsible (SPPP) has an obligation to assign a Basic UDI-DI to be provided to the UDI database, together with the other data referred to in Part B of Annex VI MDR. In order to fulfil such obligation, as from 6 months after the date of publication of the notice referred to in Article 34 (3) MDR, the SPPP will have to be registered as actor in EUDAMED before placing a system or procedure pack on the market. Member states may accept/require the use of EUDAMED for the purpose of registration in accordance with national rules, during the transition period.Registered SPPPs are assigned an Actor ID that is not a SRN."7. Who is the authority responsible for the approval of actor registration requests of SPPP located in non-EU countries?The authority responsible for approval of non-EU SPPPs actor registration requests should be the authority of the place where the first system or procedure pack of that producer is to be placed on the market. The CA may gather relevant additional information outside EUDAMED, when such information is not available inside EUDAMED, before validating a registration request.Please note that SPPP located in a non-EU country do not have an obligation to designate an AR. Therefore, the SPPP should consider providing additional relevant information to the CA, in order to facilitate the verification of the data provided for the purpose of the registration request. In the "Any other information of significance for the competent authority" field, the SPPP should specify the reason for which that competent authority was chosen. In case the non-EU SPPP acts also as a non-EU manufacturer, who has an authorised representative already designated, the authority responsible for the authorised representative should be the authority responsible for the approval of the non-EU SPPP actor registration request."This guidance should help dispel any confusion about what procedure pack assemblers need to do when it comes to appointing an authorised representative (not required), UDI requirements, registration with the EUDAMED actor module, and issuing of a SRN (there won't be one, but instead assemblers will receive an 'Actor ID' from the competent authority of the member state where the pack is placed on the market first).
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 05-Aug-2021 01:53
From: Christina Donegan
Subject: Procedure Packs and Economic Operator Verification
Thanks both. I am of the opinion though that for the procedure pack scenario that included CE marked product that are placed on the market in their own right but when combined as a procedure/system, and do not bear their own CE mark and are not considered a medical device, that the EO verification obligations would not apply. I agree though that there are so many more questions than answers with regard to these products.
Best Regards,
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Christina Donegan
Snr Regulatory Affairs Specialist
Westmeath
Ireland
Original Message:
Sent: 03-Aug-2021 01:48
From: Anonymous Member
Subject: Procedure Packs and Economic Operator Verification
This message was posted by a user wishing to remain anonymous
Hi,
If a Procedure Pack is not considered a medical device in it's own right, would it be considered then that economic operators (AR, importer, and distributor) verifications for art 22 procedure packs apply at all? When reviewing obligations of the AR, importer, and distributor (art 11-14), the obligations apply to "devices". Since art 22 procedure packs are not devices, can this interpretation be considered?
Thanks!