General obligations for authorised representatives of medical devices

Published: 13/10/2023

Changes

Authorised representative is any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf.

What requirements apply to an authorised representative?

The table below lists some of the requirements, but the list is not exhaustive. Requirements and obligations for authorised representatives are found in several parts of MDR and IVDR and it is important that authorised representatives familiarise themselves with the entire regulations. See also MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Table showing general obligations for authorised representatives of medical devices
Article	Overview of some of the requirements
MDR Article 10a IVDR Article 10a	Pass on information from the manufacturer regarding anticipated interruption in supply of a device that may result in serious harm or a risk of serious harm to patients or public health.
MDR Article 11 IVDR Article 11	General requirements for: Mandate from the manufacturer Control of EU Declaration of conformity Technical documentation The conformity assessment procedure The manufacturer’s registration and UDI Cooperate with the competent authorities by Make documentation available Assist in making devices or samples available Implement preventive or corrective measures Registration of an authorised representative Inform the manufacturer immediately about complaints and reports of incidents If the manufacturer acts contrary of its obligations Terminate the mandate with the manufacturer Inform the Norwegian Medical Products Agency and the notified body An authorised representative, together with the manufacturer, is legally responsible for defective devices.
MDR Article 11 IVDR Article 11	Requirements for replacing an authorised representative
MDR Article 15 IVDR Article 15	Requirement for person responsible for regulatory compliance
MDR Article 31 IVDR Article 28	Requirements for registration of authorised representatives and single registration number
MDR Article 95 IVDR Article 90	Requirement for procedure for dealing with devices presenting an unacceptable risk to health and safety

Overview of the different roles of economic operators:

Table showing the definition in MDR and IVDR of different roles of an economic operator
Economic operator	Definition in MDR Article 2 and IVDR Article 2
Manufacturer	A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
Authorised representative	Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
Importer	Any natural or legal person established within the Union* that places a device from a third country on the Union* market.
Distributor	Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
Health institution	An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.

*«Union» in this context means countries in the EU/EEA and Turkey.

Figure: Economic operators in the supply chain.

EU regulations on medical devices

Did you find what you were looking for?

Describe what you did not find

0/255 characters

I confirm that I do not submit any personal information, e.g. name, telephone number or email address.