LS&HC Horizons 2023 - Flipbook - Page 60
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
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EU supply chain issues for medical devices
In December 2021, the Medical Device
Coordination Group (MDCG) issued a
Q&A document (MDCG 2021-27) on the
interpretation of “importers” and “distributors”
under the Medical Device Regulation (MDR)
and the In Vitro Diagnostic Regulation (IVDR).
In short, the MDCG says that an importer of
devices is any EU-located company which first
receives ownership, possession, or any other
property title from an ex-EU-located supplier/
owner. With the role of an importer, there
come several legal obligations.
The consequence is that when, for example,
a U.S. company sells its devices from outside
of the EU to its EU customers (e.g., to sales
partners or other customers), this can trigger
the classification of customers as ‘importers’.
This would require that such partner/
customer would have to fulfil the obligations
of a distributor, including: (i) importer top
check compliance of the imported device
with regulatory law; (ii) importer to handle/
forwards product complaints; (iii) importer
to be named as importer on the product label
or accompanying documents.
Hein van den Bos
Partner, Amsterdam
In many supply chain situations this is perfectly
fine, but in others it may not be. Companies,
especially ex-EU companies, should consider:
• Should every EU customer have these
obligations? If not, they need to receive
product via an EU importing vehicle.
• How can it be ensured that, in case of several
importers (e.g., one in each EU country),
the correct importer is on the label or in
accompanying documents?
• Will hospital customers also be considered
importers? There are arguments that nonreselling end-customers are not importers.
However, this may change if there is a
second market.
• Is the so-called Swiss model (selling into the
EU via a Swiss entity) still acceptable? The
answer is likely no, but there are ways to
address this.
Dr. Jörg Schickert
Partner, Munich
