Life Sciences Horizons Brochure 2025 - Flipbook - Page 9
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2025 Horizons Life Sciences and Health Care
Medical device supply chain in EU: Involvement of ex-EU entities in supply chain
Since the enactment of the MDR and IVDR, the
authorities have been issuing several guidances,
which form the landscape for medical devices and in
vitro diagnostics (IVD) in the EU. This is also true for
the supply chain of MD and IVD, especially where
products are sold in the EU that originate from
outside of the EU (i.e., supply chains where products
are either physically shipped from outside of the EU
into the EU, or where products are sold by entities
located outside of the EU to an EU recipient). In such
cases, particular care must be taken when designing
the importation and further distribution routes and
processes of the MD or the IVD.
The MDR and IVDR both define the roles of an “importer”
and a “distributor,” and impose certain obligations on
those entities. The guidance that clarifies the definitions
and obligations of importers and distributors (MDCG
2021-27) states: where a product comes from outside of
the EU, the European legal entity which first obtains
the product from outside the EU by way of receipt of
ownership, possession or any other property right will
be deemed the importer. It further says that even an
entity which only buys a product and receives ownership
– without physically touching the product – will be
considered an importer.
Critically, these laws require that the very entity that
purchases a product from outside the EU must fulfill the
obligations as an importer (e.g., ascertaining on a certain
level that the MDR or the IVDR has been complied with,
and being the contact point for authorities). Further, the
importer has to be mentioned on the product packaging
or “accompanying documents.”
Clearly, an ex-U.S. devices company selling products
directly to EU customers must avoid its customers (e.g.,
hospitals, orthopedic technicians, medical aid providers)
needing to take upon themselves the role and obligation
of an “importer.” Thus, the distribution and importation
chains have to be organized in such a way that a company
that is capable of fulfilling that role is introduced into the
supply chain.
Once such an importing entity is set up, it must ensure it
is able to meet all MDR or IVDR requirements; or, that by
way of intercompany or third-party company agreements,
the regulatory obligations accompanying the role of an
“importer” are sufficiently addressed and fulfilled.
Dr. Jörg Schickert
Partner
Munich
Tier 1
for Healthcare
Legal 500 Germany, 2025
