EU Responsible Person & EU Authorized Representative Services

• What an Authorized Representative is?

A medical device European Authorized Representative (EAR) serves as a legal European Company to work on behalf of a foreign manufacturer.  This EAR is designated by non European Union (EU) medical device manufacturers, to represent them in the EU and ensure their compliance with the European Regulations.

The Authorized Representative is the entity to which the authorities and institutions of the EU Member States may address the obligations set out in the legal requirements for medical devices. A medical device authorized representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. 

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• Which the responsibilities are?

An medical device Authorized Representative holds the responsibility to act as a neutral party between the competent authorities and the non EU medical device manufacturers. They must ensure the medical device manufacturer is in compliance with the conformity assessment procedure set out in the European regulations which apply to the manufacture's product.

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• Who should report any vigilance problem?

The medical device Representative or EC Rep must uphold dual accountability with the medical device manufactures if problems or questions arise regarding the medical device. It also must provide their contact information for the medical device manufacturer to place on the products, allowing the EC Rep to be the primary contact for EU authorities.

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• What the Declaration of Conformity is?

In the same way, the CE certificate and the declaration of conformity of the medical devices can only be issued by a company located in the European Union, in this case the Authorized Rep.

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• What is a European Authorized Representative (EC Rep) for?

According to the MDR 2017/745, the medical device EU Authorized Representative (EC Rep) is any natural or legally established person in the European Community, who is explicitly designated by the medical device manufacturer to act on its behalf. This person/company may be consulted by Authorities and Bodies regarding the requirements of Directives / Regulations. The EUAR is responsible for the medical devices and foreign manufacturer in the EU.

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• What are the functions of an Authorized Representative?

The role of an Authorized Representative is varied and challenging. The main functions include, but are not limited to, the following:

• Make the manufacturer and medical devices registrations

• Provide a registered address within the European Union for the medical devices

• Keep all technical documentation of the medical devices manufacturers available for inspection by the Authorities

• Complete notifications to the Authorities regarding the medical devices

• Complete any registration of medical devices in the national databases

• Handle any incident reports from medical devices

• Represent the medical device manufacturer before the European Commission, Authorities and Notified bodies

• Safeguard and ensure compliance with constant regulatory updates for the medical devices

• Consultancy in Medical Device European Regulations

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AF Pharma Service is registered in the EUDAMED database as medical device EU Authorized Representative (EC Rep). We help our medical devices manufacturers to be part of EUDAMED making the medical device manufacturer and medical device registration in the European EUDAMED database. 

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We offer medical device EU authorized representative services, Regulatory and Quality consulting services and import solutions, along with regulatory consulting with our partners located around the world. Also, we are certified for Medical Devices under MDR 2017/745, for Invitro Diagnostics under IVDR 2017/746, as long as the old MDD, AIMD and IVDD certifications.