EU Authorised Representative

MDR Regulator acts as an Authorised Representative to effectively assist the Manufacturer in complying with European legal requirements.

What is the role of the EU Authorised Representative?

A manufacturer established outside the European Union is obliged to appoint an authorised representative within the EU. The authorised representative acting on behalf of the manufacturer is responsible for medical devices placed on the European market. He is the entity to which the authorities and institutions of the Member States may address the obligations set out in the legal requirements for medical devices. An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer.

As an authorized representative we offer

• development/verification of product technical documentation;
• making the technical documentation available to the competent authorities for inspection,
• assistance in product certification,
• product registration,
• supporting device safety activities (FSCA), such as medical incident reporting.

Who appoints the EU Authorised Representative?

A manufacturer established outside the European Union is obliged to appoint an Authorised Representative.

What are the responsibilities of an authorised EU representative?

In addition to the already mentioned obligation to contact the authorities, institutions of the Member States, including the supervisory authorities, the authorised representative has an obligation:

• keep the technical documentation or the declaration of conformity available for inspection by the authorities of the Member States upon request,
• ensure that the product is correctly labelled,
• respond in case of a medical incident,
• registration of the product in the relevant Office,
• take part in safety corrective actions (FSCA)

How do you choose an independent authorised representative?

The authorised representative should be an independent organisation acting in agreement with the manufacturer. You may have multiple distributors in your distribution network who are experts primarily in sales and marketing, not necessarily in legal requirements. In case of problems in the distribution system and related problems with legal requirements, the distributor will always defend his own company. If you are considering appointing a distributor as an authorised representative for your company, consider the following:

• the authorised representative has access to the full technical documentation, including information on the project,
• an authorised representative should be kept informed of any changes in legal regulations and should warn your company of the changes well in advance,
• the authorised representative should be able to represent the Manufacturer adequately and answer all questions from the Competent Authorities concerning the manufacturer’s medical devices,
• the authorised representative is appointed in all information materials: labels, packaging, instructions for use.

What are obligations of the autorised representative in the EUDAMED database?

After the Eudamed will be fully functional, economic operators (including authorised representatives) should be registered in this electronic system for registration. Each Authorised Representative, which fulfill obligations mentioned in the MDR should obtain a single registration number (SRN) and can be verified in a public database.

MDR Regulator is an Authorised Representative according to the MDR. Our SRN number: PL-AR-000002485.

Source:
MDR in EUDAMED database