Hi Anon, there is a new piece of EU legislation coming into force soon that provides at least some of the answers to your questions, and also to previous discussions on this forum regarding importers/distributors. This is '
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011', for which a guidance also exists. This is a generic regulation, but it does apply to medical devices, among other product types.
This regulation clarifies that when a non-EU entity sends a product direct to an end user in the EU, there is no importer, and that the non-EU entity is responsible for 'making the product available on the market' (rather than for 'placing on the market').
It also identifies that for any product that is available on the EU market, for it to be 'legal', there must be an entity ('economic operator') that takes responsibility for it within the EU. There are four types of economic operator identified that are able to take on this responsibility:
1. A manufacturer established in the EU
2. An importer (by definition established in the EU), where the manufacturer is not established in the Union
3. An authorised representative (by definition established in the EU)
4. A fulfilment service provider established in the EU where there is no manufacturer, importer or authorised representative established in the Union
'Fulfilment service provider' is defined as: 'any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services, and any other postal services or freight transport services'
When there is no importer or fulfilment service provider for a product from outside of the EU, the authorised representative must take on responsibility for the product in the EU.
With this background, turning now to your questions:
In the first scenario, there is no importer or fulfilment service provider, because the UK company is making the device available on the EU market by supplying it directly to an end user (presumed to be via a postal or parcel delivery service). The French manufacturer will be responsible for it once it is with the end user because it fulfils one of the required economic operator roles required by Regulation 2019/1020, as an EU manufacturer, even though it did not 'place the device on the market'.
In the second scenario, a similar situation exists except that the German authorised representative now must assume responsibility for the device once it is with the end user, because it fulfils one of the required economic operator roles in 2019/1020, there being no EU manufacturer, importer or fulfilment service provider.
One final point, the date of application of Regulation 2019/1020 is 16 July 2021. Non-EU device manufacturers may need to review their agreements with importers and authorised representatives to take account of this new regulation.
------------------------------
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: 16-May-2021 10:51
From: Anonymous Member
Subject: Placing on the market
This message was posted by a user wishing to remain anonymous
Hello,
there are so many different scenarios regarding placing product on the market. While some are very straightforward, other may be confusing. I am interested in your take on the following scenarios:
1. Manufacturer is in France sells its devices to a company in UK. The company in UK then sells it directly to a hospital in the EU. When the French company sells it to the UK company, it is not placing on the market because UK is not in EU. Is transaction of selling goods from the UK company to the hospital in the EU considered placing on the market? Can a non EU company place product on the EU market? If so, there would be no importer per MDR definition. Or is the manufacturer in France considered as an entity placing product on the market in the EU and importer of the product (even though it went through UK channel)?
2. Manufacturer in the US sells its devices to a company in UK. The company in UK then sells it directly to a hospital in the EU. Important detail: the company in US has an AR in Germany and this AR is indicated on the label. When the US company sells it to the UK company, it is not placing on the market because UK is not in EU. Same question as above- is transaction of selling goods from the UK company to the hospital in the EU considered placing on the market? Can a non EU company place product on the EU market? If so, again, there would be no importer per MDR definition.
Thank you for help!