An authorised representative is defined as being any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations.
The Regulations describe the responsibilities of authorised representatives. Many of the general obligations of authorised representatives are described in MDR/IVDR Article 11. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.)
The Regulations also describe the tasks that can be delegated by the manufacturer to the authorised representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate.
At a minimum, authorised representatives’ obligations include verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer (MRD/IVDR Article 11(3)(a)).
An authorised representative must also keep copies available of all documents and make them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements (MDR/IVDR Article 11(3)(b)).
In addition, authorised representatives will have to verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVDR Article 11(3)(c)).
An authorised representative will have to cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
The authorised representative will be liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU (MDR/IVDR Article 11(5)).
The authorised representative should terminate the mandate if the manufacturer acts contrary to its obligations (MDR/IVDR Article 11(3)(h)). In such situations, the authorised representative shall immediately inform the Member State in which it is established and, where applicable, the Notified Body involved in the conformity assessment of the device, of the termination and the reasons behind it.
The Regulations also describe activities that cannot be delegated to an authorised representative, and that may not be part of the mandate between a manufacturer and an authorised representative (MDR/IVDR Article 11(4)). Examples include requirements related to the design of a device, the quality management system, or the drafting of technical documentation; these are the exclusive responsibilities of the manufacturer.
The authorised representative should have permanent and continuous access to a person responsible for regulatory compliance (MDR/IVDR Article 15(6)).
A change of authorised representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised representatives (MDR/IVDR Article 12).
Guidance
Guidance is also available from the Medical Device Coordination Group
- MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
as AR do we need to obtain ISO 13485 certification to be able to perform as AR and get registered at EUDAMED.
Do we need to have technical qualification to provide AR services for specific device group (similarly like some auditors can perform TD review of the certain products, based on their qualification)?
Someone acting as an Authorised Representative must be able to fulfil the obligations and responsibility described in Article 11, but no quality management system requirements or technical qualifications are required by Article 11.
There is also a guidance document on the topic: MDCG 2022-16 https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en?filename=mdcg_202216_en.pdf
We are seeking a consultant to walk us through getting the MDR certification. Any suggestions?
Hello
I need information to get MDR, who one guide me, how can I sell my company surgical instruments in EU markets?
as an AR, do we need to register the devices mandated by manufacturer to any member state that we are in.
EUDAMED is a cross EU database. Meaning, operators such as Authorised Representatives only register once in EUDAMED independent of how many member states their devices are supplied distributed in.
I would like to view the certificate that a firm called Biomedis in Great Britain claims has been issued by the EU for a device it is selling.
Can you tell me please where I can find that certificate?
Thank you.
You can search in EUDAMED for certificates
https://ec.europa.eu/tools/eudamed/#/screen/certificates
Do the authorized representative need to hold few SOP for example SOP for collection of marker complaint, SOP for recall or any other SOP?
This question is not directly addressed by the EU MDR but should be discussed with the manufacturer that appoints you. It depends. Your company must have at least one document, the written mandate from the manufacturer which lists the tasks to be performed as their representative (See Article 11 (3) (a) to (h)). Maybe, if your company is a sole person operation, and the mandate from the manufacturer is sufficiently detailed, you won’t need SOPs. If your company is more complex, then probably you will need SOPs.
Is there a guideline or procedure available to become Authorised Representative for non EU manufactueres?
To become an authorised representative you/your company must be based in the EU and receive a mandate from a manufacturer. Meaning, the manufacturer must appoint you to be their authorised representative. In this way the authorised representative role is different o the roles of importer or distributor.
The tasks covered by the (appointment) mandate are listed in Article 11 (3) of the EUMDR. So, at minimum, you/your company will need to be able to perform the tasks listed. There is also a MDCG guidance document MDCG 2022-16 which says the same.
Dear Madam/Sir,
I would like to check if a distributor from outside the EU of medical products such as latex gloves, Disposable syringes, compresses, sticking plaster and Dietary supplement must have a representative in Europe to sell those products in the EU markets.
Thank you for your assistance.
Best regards,
In the EU MDR “distributor” always means someone in the supply chain who is based inside the EU market. So, by definition an EU distributor does not need a representative in the EU.
If you are considering obtaining a medical device from a supplier based outside the EU market, it is the original manufacturer of that device who is responsible for compliance with the EU MDR, and that includes appointing an authorised representative within the EU. A non-EU distributor cannot do these things unless he assumes the responsibilities of the manufacturer.
is there a list of ARs for the EU MDR? Can I please get a copy?
You can search in the EUDAMED database of economic operators at the following link; https://ec.europa.eu/tools/eudamed/#/screen/search-eo