MDR Economic Operators: Responsibilities Across the Chain

The European Medical Device Regulation (MDR 2017/745) does not rest on the manufacturer alone.

To strengthen patient safety and improve market surveillance, the European legislator defined several economic operators, each with responsibilities of its own.

Depending on your activity, you may be:

a manufacturer;
an EU authorised representative (EC REP);
an importer;
a distributor.

And in some cases, one company may combine several of these roles. What matters is knowing which obligations actually apply.

The objective of the MDR is simple: to create a chain of control in which each actor plays a complementary role, so that a non-compliant medical device cannot be marketed. Each economic operator must carry out checks of its own before passing the device on to the next link. This succession of checks considerably reduces the risk of a non-conformity going unnoticed.

The manufacturer: responsible for compliance

The manufacturer holds a central place, since it is the one that designs, manufactures or has the medical device manufactured and that bears overall responsibility for its compliance.

It must in particular:

put in place a quality management system;
compile the technical documentation;
carry out the clinical evaluation;
draw up the EU declaration of conformity;
affix the CE marking;
organise post-market surveillance (PMS);
manage vigilance.

Even where it subcontracts certain activities, the manufacturer remains responsible for the device’s compliance throughout its life cycle. That responsibility cannot be transferred.

The EU authorised representative (EC REP)

This is the gateway to the European market for a manufacturer established outside the European Union. Without an authorised representative, a manufacturer not established in the Union cannot place its devices on the Union market (Article 11(1)); what counts is where the manufacturer is established, not where the device is manufactured. The authorised representative represents the manufacturer before the competent authorities. But be careful: its role is not to make the device compliant.

It must, however, in particular:

verify that certain regulatory documents have been drawn up;
keep certain documents available to the authorities;
cooperate with the competent authorities;
forward their requests to the manufacturer;
take part, where necessary, in corrective and vigilance actions.

The authorised representative is an independent economic operator with regulatory obligations of its own. It primarily exercises regulatory and documentary control.

For a manufacturer established outside the Union, that chain starts with appointing an authorised representative: see our EU representation service (EC REP).

The importer

The importer is the first link to physically introduce the device onto the Union market.

Before that placing on the market, it must in particular verify:

that the device bears the CE marking where required;
that the EU declaration of conformity has been drawn up;
that the manufacturer has appointed an authorised representative where this is mandatory;
that the device is labelled in accordance with the MDR and accompanied by the instructions for use;
that the manufacturer has assigned a UDI, where applicable.

The importer must also indicate its own details on the device, on its packaging or in a document accompanying the device (Article 13(3)).

The importer thus plays an essential role as the first check on the product before it accesses the European market.

The distributor

The distributor comes in after the placing on the market. Before making a device available to its customers, it must verify, as part of its obligations:

the presence of the CE marking and that the EU declaration of conformity has been drawn up;
the information on the labelling and the presence of the instructions for use;
for an imported device, that the importer’s details are indicated;
that the manufacturer has assigned a UDI, where applicable.

These various economic operators also contribute to market surveillance by reporting incidents or risks that come to their knowledge.

Can one company hold several roles?

Yes. The MDR defines functions, not types of company. One company may therefore perform several roles depending on the products concerned.

For example:

a company that imports devices and then resells them in France or in the EU is both importer and distributor;
an EU authorised representative that imports devices into the EU is both authorised representative and importer.

Each role brings specific obligations that add up on top of one another.

Preserving independence… and the manufacturer’s strategic interests

Beyond the regulatory requirements, it can be wise for a manufacturer established outside the European Union to separate the roles of authorised representative, importer and distributor.

Each of these operators indeed has access to different, strategic information.

The authorised representative has access to the technical documentation, the regulatory data, the clinical files and, more broadly, the know-how needed to demonstrate the device’s compliance.

The importer and the distributor, for their part, have privileged knowledge of the market: customer expectations, sales volumes, distribution networks, commercial practices and field feedback.

Where several of these functions are entrusted to a single company, that company concentrates both the technical knowledge of the product and the commercial knowledge of the market.

Without necessarily being a problem, that concentration can increase dependence on a single partner and make a change of provider or of commercial strategy more difficult.

For many manufacturers, particularly as they develop their presence on the European market, it is therefore preferable to spread these functions across several independent actors, in order to preserve both the confidentiality of their know-how and their commercial freedom.

Importer or distributor: beware of becoming a manufacturer

This is one of the least known situations, and yet it is clearly framed by the MDR.

A distributor or an importer may be considered a manufacturer if it:

markets a device under its own name or its own trade mark;
changes the intended purpose of the device;
modifies a device in a way liable to affect its compliance.

In that case, it no longer falls solely under Articles 13 or 14 of the MDR but becomes subject to all the obligations applicable to the manufacturer.

That reclassification can have significant consequences in terms of technical documentation, clinical evaluation, post-market surveillance and liability.

The MDR nonetheless provides for certain exceptions to this rule. Under precise conditions, an importer or a distributor may market a device under its own name or its own trade mark without being reclassified as a manufacturer. That possibility rests in particular on an agreement concluded with the legal manufacturer, whereby the latter remains clearly identified as the manufacturer within the meaning of the MDR and continues to assume all the regulatory obligations incumbent on it. This arrangement must be formalised carefully to avoid any ambiguity about the allocation of responsibilities.

Why does this allocation matter?

The MDR can be compared to a succession of independent viewpoints, in which each economic operator checks the elements within its own scope before the device continues its journey towards the end user.

The manufacturer demonstrates compliance. The authorised representative verifies that the required regulatory elements have indeed been drawn up. The importer performs the checks required before the first placing on the European market. The distributor carries out the verifications incumbent on it before making the device available.

This arrangement limits the risk of a non-conformity escaping every actor in the chain.

The most frequent mistakes

In our practice, several mistakes recur regularly:

thinking the authorised representative becomes responsible for the device’s entire compliance;
believing the importer is a mere logistics provider with no regulatory obligations;
treating the distributor as a mere reseller;
overlooking that one company can combine several roles;
marketing a device under one’s own brand without realising this can lead to reclassification as manufacturer.

Correctly identifying each operator’s role is nonetheless essential in order to build an MDR-compliant organisation.

In summary

The MDR shares responsibilities among several economic operators in order to strengthen the safety of medical devices placed on the European market.

Each actor — manufacturer, authorised representative, importer or distributor — has obligations of its own. One company may combine several roles, but it will then have to meet all the requirements applicable to each of them.

Before marketing a medical device, it is therefore essential to identify precisely the role played by each party in the supply chain.