MDR Article 11: What Transfers to Your Representative and What Never Can

MDR Article 11 is usually described in general terms by the providers who sell authorised representation. The article itself is specific, and reading it carefully changes how the service should be bought.

What MDR Article 11 requires of you

A manufacturer not established in the Union appoints a sole authorised representative before its device is placed on the Union market. The appointment is made in writing and is valid only when accepted in writing by the representative.

The mandate covers all devices of the same generic device group. You may appoint different representatives for different device groups, but not two representatives for the same group.

The word “sole” is doing work here. There is no arrangement in which two representatives share responsibility for one device family, and no threshold below which the requirement stops applying — a Class I device carries the same appointment obligation as a Class III implant.

What MDR Article 11(3) transfers

Article 11(3) sets out the minimum tasks the mandate must cover. The representative verifies that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that the appropriate conformity assessment procedure has been carried out by the manufacturer.

It keeps a copy of the technical documentation, the EU declaration of conformity and any relevant certificate available for competent authorities for the period specified in the regulation. It complies with the registration obligations and verifies that the manufacturer has complied with its own.

It acts as the contact point in the Union, forwards requests for samples or access to a device to the manufacturer, cooperates with competent authorities on preventive or corrective action, and immediately informs the manufacturer about complaints and reports from healthcare professionals, patients and users concerning suspected incidents.

Note the verb in the first task. The representative verifies that documents have been drawn up. It does not draw them up.

What MDR Article 11(4) keeps with the manufacturer

Article 11(4) is explicit about what a mandate cannot delegate. Device design, manufacture and the quality management system remain the manufacturer's responsibility. So does the drafting of the technical documentation and the declaration of conformity.

A provider offering to take these over is describing something the regulation does not permit. The mandate may include additional tasks by agreement between the parties — regulatory support, translations, data preparation — but agreement cannot move an obligation the regulation places on the manufacturer.

This matters commercially as well as legally. A manufacturer who believes it has outsourced its technical documentation has bought a service that does not exist, and will discover this at the worst possible moment.

The liability provision in MDR Article 11(5)

Article 11(5) is short and consequential. Where a manufacturer established outside the Union has not complied with its obligations, the authorised representative is legally liable for defective devices on the same legal basis as, and jointly and severally with, the manufacturer.

This provision explains a great deal about how competent representatives behave. A representative that examines your technical documentation before signing is acting in its own interest, not performing a courtesy. One that signs without reading is carrying an exposure it has not assessed — which should concern you rather than reassure you, because a provider careless with its own risk is unlikely to be careful with yours.

Termination and what follows

Where a representative terminates the mandate, it informs the competent authority of the Member State in which it is established and, where applicable, the notified body involved in the conformity assessment. It also informs them of the reasons for termination.

A mandate that ends badly is therefore visible to the authority, not a private commercial matter. Article 12 governs what happens next, and it requires agreement between the manufacturer, the outgoing representative and the incoming one.

Joint and several liability between manufacturer and authorised representative under MDR Article 11(5)

Sources

Regulation (EU) 2017/745, Article 11 — authorised representative

Regulation (EU) 2017/745, Article 12 — change of authorised representative

Regulation (EU) 2017/746, Articles 11 and 12

MDCG 2022-16 — guidance on authorised representatives, Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We examine technical documentation during due diligence rather than after a competent authority asks for it. We are not a law firm and do not provide legal advice.

Medex provides EU authorised representation under Article 11 for manufacturers outside the Union. Where an existing mandate has to be transferred, our note on change of authorised representative sets out what Article 12 requires of all three parties.