Think about how your product will be distributed across Europe. Distributors have obligations, including checking that the devices they distribute comply with the regulation and reporting complaints and suspected serious incidents. Consider how will you provide your distributors with the information they need, and vice versa.
If yours is an enterprise which is not based in the EU there are additional steps:
You will need to appoint a legal representative within the EU to act on your behalf. According to Article 11 all foreign manufacturers must appoint an “Authorised Representative”. It can be a company or an individual. The role is primarily to act as your representative in front of the Authorities. You will need to decide the scope and mandate of your Authorised Representative (see Article 11, 2).
Consider appointing one specific “Importer”. Anyone who imports your product into the EU also has obligations (see Article 13) in addition to those of the Authorised Representative. Like Authorised Representatives, Importers must also register with the Authorities. Like Authorised Representatives the name and address of the importer must also be on or accompanying the product in the distribution chain. But Importers must also keep records of complaints and inform the authorities of reports of serious incidents involving the product. Importers have to work closely with Authorised Representatives. Therefore, it is worth considering whether the same legal entity could fulfil the roles of both Authorised Representative and Importer for your device.
Deliverables for demonstrating compliance:
(1) Agreements with an Authorised Representative, Importer(s) and/or Distributor(s) as applicable.
Guidance available from the Medical Device Coordination Group:
- MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
We are a UK based company that imports and distributes Class 1 medical devices from the USA and places them on the market in the UK; currently with a CE mark and will have to transition to a UKCA mark following Brexit. Assuming the products are compliant, can we go on to distribute (or “import”) these same products in the EU without taking steps to establish a company in the EU?
The assumption is that your question relates to the EU MDR and not UK-EU customs arrangements. Also, that these are legacy MDD devices, not new MDR compliant devices. Nevertheless, there are many considerations:
Does the manufacturer have an EU based Authorised Representative? Were the devices only registered and placed on the market in the UK previously? Does the manufacturer intend to take advantage of the transitional provisions for these legacy devices? They may need a new EU based Authorised Representative and Importer, new registration etc. You are recommended to seek the advice of a regulatory professional. It is not enough that the devices are CE marked.
If a company manufactures medical devices in the US, and has an AR and Importer which all operate under a divisional QMS certificate (MDR compliant) and sell through their European subsidiaries (again operating in same QMS) and running same IT systems globally etc are they regarded as distributors under the MDR?
If so, is there a list of countries in Europe which requires registration of distributors (under Article 30)?
Each European subsidiary will almost certainly be a legal entity in its own right; i.e. a business registered locally according to the laws of the country where it operates. As such, each subsidiary will likely fulfil the definition of a distributor and, depending on the corporate business model, maybe also an importer.
Collecting information on the registration requirements in each country is often a task of an industry association.
Do we appoint one importer for the whole of the EU or does each of our distributors have to register as an importer?
If your company has exported products to the EU in the past, you have already dealt with importers and distributors even if you were not aware of those designations. This is because any EU legal entity, or EU citizen, who places a product from a third country on the Union market is, by definition, an importer. Anyone else involved in the supply chain is, by definition, a distributor. The roles and the obligations of importers and distributors are not newly created by the EU MDR, neither are they unique to the medical devices sector. The majority of the importer and distributor obligations described in the EU MDR have existed for years already in other EU legislation.
If your company wants to trade with one importer or multiple importers, you are free to decide. It is a business decision. It is a different situation with the authorised representative; as a third country manufacturer your company has an obligation to designate and mandate an single authorised representative. But there is no such obligation on manufacturers to designate and/or mandate an importer.
Hello, I’d like to point at what Raj said on May 27th – if, for example, a Swiss manufacturer exports medical devices to France, Spain, Germany and Austria, do they need to extablish only one importer and teh rest are distributors? For example they make their French partner the importer and the Spanish, German and Austrian partners remain distributors? Thank you!
The importer is not mandated by the manufacturer like the authorised representative. Any person established in the Union that imports a device from a third country and places it on the Union market is an importer. Whereas, a distributor is a person in the subsequent intra-Union supply chain. i.e. Importers import devices and supply distributors.