A couple of questions, Anon:
1) Why is your NB getting involved in procedure pack (PP) issues? Unless you are CE marking the PP as if it was a single MD in accordance with Article 22(4), either sterile Class I or Class IIa/IIb/III, MDR Article 22 allows compliance by self-declaration by the Assembler, without any input from an NB.
2) Nowhere in the MDR, even for CE marked devices, is there an obligation on an MD manufacturer (or PP assembler) to include importer details on the labeling at the time of dispatch to the EU. The obligation for the importer to be identified is an obligation on the importer, not the manufacturer, as detailed in MDR Article 13, so why is your NB apparently implying that this is a manufacturer obligation?
Have I misunderstood anything?
------------------------------
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 07:41
From: Anonymous Member
Subject: Procedure Pack Labelling - Importer details
This message was posted by a user wishing to remain anonymous
Hi,
For Procedure Packs labelling, does anyone know if the importer must be identified? There is no explicit statement for this in the MDR, however it seems some Notified Bodies have shown a preference for this information to be on the label?