Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi

If a company manufacturing devices inside the EU are selling to a main distributor based in the UK, who then in turn distribute to numerous sub-distributors within the Eu. Will the sub-distributors in the EU that receives a EU manufactured CE marked medical device from a UK distributor, be regarded as an importer? They make the device available on the marked, however the device has already been placed on the marked directly by the manufacturer in certain EU member states.

Remember that "placing on the market" is a unit-based concept, not a model-based concept.  Accordingly, a given model will have many placings on the market during its market tenure.  Because of this, when a manufacturer inside Europe's Union (which by the way is different than, yet includes, the European Union) exports a device(s) outside of the Union into the UK to a UK distributor (an economic operator), then those device units/shipments have been placed on the UK market, not the Union market (except for Northern Ireland who for these purposes is considered part of Europe's Union). Thus, when those same units/shipments are subsequently sent back into Europe's Union by the UK distributor, then that is actually the first making available (the placing) on the Union market.  Thus, any distributor in the Union who first receives such unit from the UK distributor (or from any other third country outside the Union) will automatically (legislatively) be the Union importer of that unit unless you have previously set up a "virtual importer" arrangement with another Union economic operator who is fulfilling the importer role.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 17-Apr-2024 10:29
From: Anonymous Member
Subject: Supply from UK distributors of MD manufactured inside the EU back into the EU

This message was posted by a user wishing to remain anonymous

Hi

If a company manufacturing devices inside the EU are selling to a main distributor based in the UK, who then in turn distribute to numerous sub-distributors within the Eu. Will the sub-distributors in the EU that receives a EU manufactured CE marked medical device from a UK distributor, be regarded as an importer? They make the device available on the marked, however the device has already been placed on the marked directly by the manufacturer in certain EU member states.

Hi Anon,

like Kevin says the placing on the market is done for an individual device, so it does not help that other devices with the same REF are also placed on the market directly in member states.

However, the concept of import in the sense of the MDR does not really account for re-import but usually assumes that the "device from a third country" that is placed on the market by the importer comes from a legal manufacturer based in that third country (and that consequently e.g. needs an Authorised Representative), which is not true in your case (assuming that "manufacturing devices inside the EU" means that the legal manufacturer is located inside the EU). In consequence some of the requirements for the importer do not really make sense, like checking for an AR and providing their name and address to have a place of contact inside the Union. So I am not really sure if the MDR concept of importer really applies here (see e.g. this discussion).

The Blue Guide that gives an interpretation on the general concepts states in footnote 135: "For the purposes of this Guide, imports are products manufactured in third countries and placed on the Union market. Products manufactured in one Member State and placed on the market in another Member State do not constitute an 'import' as the operation takes place within the Union internal market." Again this does not really cover your scenario that is somwhere in-between.

If the sub-distributors are importers for other devices anyway and have a registration and procedures to provide their name in place, it probably would not matter to have them act as importers. If not, one possibility to avoid this additional effort would be to formally place the devices on the market via a third economic operator within the EU, that then sells them to the main distributor in UK. That way the individual devices would already have been placed on the market in the Union and the re-import would unambiguously fall outside of the importer definition.

Best regards, Christoph

------------------------------
Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
------------------------------

Original Message:
Sent: 17-Apr-2024 10:29
From: Anonymous Member
Subject: Supply from UK distributors of MD manufactured inside the EU back into the EU

This message was posted by a user wishing to remain anonymous

Hi

If a company manufacturing devices inside the EU are selling to a main distributor based in the UK, who then in turn distribute to numerous sub-distributors within the Eu. Will the sub-distributors in the EU that receives a EU manufactured CE marked medical device from a UK distributor, be regarded as an importer? They make the device available on the marked, however the device has already been placed on the marked directly by the manufacturer in certain EU member states.