2024 EU MedTech Outlook: Economic Operators

By Elizabeth Pugh and Evangeline Loh

The Medical Device Coordination Group (MDCG) has published guidance to facilitate the interpretation of the roles involved in gaining access to the European medical device market.

Revisions to guidance documents define roles

Last December, the MDCG posted revisions to two of these guidance documents, including the Questions and Answers document on Articles 13 and 14 of the regulations regarding importers and distributors, respectively (MDCG 2021-27). This guidance, in addition to the Blue Guide, provides a consensus interpretation of the economic operators (EO) of the EU New Legislative Framework defined in 2008 as:

1. Manufacturer
2. Authorized Representative (AR)
3. Importer
4. Distributor

The Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746) incorporated the term and definition into the legislation and imposed significant responsibilities on these entities. The manufacturer and the AR must appoint a Person Responsible for Regulatory Compliance (PRRC).

Under the Regulations, the manufacturer, AR, and importer must be registered in EUDAMED. Each entity requires a separate Single Registration Number (SRN) for the role, designated with the two-letter: MF, AR or IM. In addition, an assembler or “producer” of a system and procedure pack (SPP) needs a SRN, identified by PR (producer).

Seminal considerations based on updates to MDCG 2021-27, Rev. 1

Both the AR and importer must be based in the EU. This natural or legal person based in the EU can function as both the AR and the importer, as the roles are different (new Question 16). By definition, an importer cannot also be the distributor (new Question 17).

A fulfillment service provider (FSP) is generally not an importer or a distributor. As the guidance stated, neither is likely a third-party logistics (3PL) provider. However, individual shops, community pharmacies, retailers or other persons could be. Consumers generally are not importers or distributors, as they don’t place devices on the market or make devices available on the market.

In addition, an entity that is an assembler of an SPP may also be functioning as an importer or a distributor based on the “transfer of ownership, possession or any other property right” (new Questions 24 and 25).

Role definitions set the rules

The definitions in the regulations set the ground rules. A manufacturer based in the EU can never have an AR or an importer. A manufacturer not based in the EU transfers ownership of the devices to an EU entity and becomes the importer.

For entities based in the EU, assessing how legal rights are being transferred in addition to the tasks performed is important. While tasks can be subcontracted, the EO remains responsible for the devices based on their role.