Yes, Confusion Everywhere!
There are a number of factors playing into this problem, not least of which is that the MDCG and Eudamed3 developers have decided in their wisdom to require things that are not specified in the MDR, including the registration of procedure pack assemblers. MDR Article 31 is titled
"Registration of manufacturers, authorised representatives and importers", and not
"Registration of economic operators", presumably because the authors of the MDR saw no need for assemblers (who are defined as one of the 'economic operators') to be registered in Eudamed. MDCG and Eudamed developers have decided otherwise, though, and now we have the mess where assemblers are required by Eudamed to obtain a SRN, but for non-EU assemblers, this can't be done without having an EC REP, which as other responders in this thread have opined, is not required by the MDR.
Unfortunately,
MDCG 2020-15 includes what appears to be a blatantly incorrect statement, based on the title of MDR Article 31, by saying:
"In accordance with Article 30(1) MDR, the actor registration module shall allow for the creation of a unique single registration number ('SRN') referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer (including producers of system/procedure packs) and, where applicable, the authorised representative and the importer." Not only does Article 31 not require this, but also Article 30(1), as referenced in MDCG 2020-15, does not require this, stating very explicitly that:
"The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer." So this is where it all starts to go awry.
Having stated above that non-EU assemblers do not need an EC REP, that appears to be true unless one interprets the wording of Article 22(5) to mean that a non-EU assembler must have an EC REP! This interpretation comes about from this wording in Article 22(5):
"Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I." Annex I Section 23 refers, of course, to manufacturer's obligations, so do we presume that in applying Section 23 to procedure packs, we must replace "manufacturer" with "assembler"? If so, then Section 23.2(d) requires the assembler to designate an EC REP if located outside of the EU.
Is the Commission or MDCG working on explicit, practical guidance on these points? There's nothing in the "
Ongoing guidance development" list that suggests they are, so we will just have to continue to stumble around in the dark for the time being, trying to unravel seemingly contradictory requirements, guidance and NB opinions!
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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: 06-Apr-2021 05:52
From: Katarzyna Chrusciel
Subject: Procedure Pack Labelling
I totally agree with you Richard Vincins!
We are not ready at all...
K
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Katarzyna Chrusciel
Engineer
Cavezzo
Italy
Original Message:
Sent: 06-Apr-2021
From: Richard Vincins
Subject: RE: Procedure Pack Labelling
Have been watching the thread and already confused by different acronyms already being used PP, PPP, SPP. Procedure Pack manufacturers have been well mis-understood under the EU MDD and gotten even worse under the EU MDR. When the EU MDR was published I was really hoping Article 22 (from the Article 11) would provide more substance or even *gasp* an Annex for procedure pack requirements. Alas, it is no better and what compounds this even more is there is absolutely no consistency between Notified Bodies. I have seen some wanting a CE Mark, DofC, Tech Doc file for procedure packs and others only want to see CE Certs for the individual products in the procedure pack. The challenging question also is: does procedure packs need to be reviewed by a Notified Body even? To answer the original question regarding does an AR need to be on the label --- maybe, probably not. As mentioned previously, they may be considered an Economic Operator, but not considered a Manufacturer. And also makes it more confusing is under EUDAMED a System & Procedure Pack Producer is considered an Actor and required to obtain an SRN and register the establishment.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 05-Apr-2021 06:47
From: Michael Maier
Subject: Procedure Pack Labelling
Hi,
If the SPP (system and procedure packer) is located within the EU he does not need an EC REP. If the SPP is outside EU, then the SPP needs to obtain an SRN over the competent authority of the member state where the importer is located. Whether this will work remains unclear. Alternatively, the SPP outside EU may designate an EC-REP and then obtain the SRN over the CA of the member state of the EC-REP. We have requested commission services for clarification quite some time ago already and were told there will be some clarification....(unspecified when however...)
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Michael Maier
Senior Partner - Medidee Services AG
Switzerland
michael.maier@medidee.com
Original Message:
Sent: 02-Apr-2021 01:53
From: Anonymous Member
Subject: Procedure Pack Labelling
This message was posted by a user wishing to remain anonymous
Hi
For products that are CE-Marked within a procedure pack under Article 22 of the MDR, does the Procedure Pack label need to state the Authorised Rep details?
Thank You,