EU Authorised Representative for Medical Devices

What is an EU Authorised Representative?

An EU Authorised Representative is one of the economic operators within the customs territory of the European Union. The MDR and IVDR defines this economic operator as follows:

‘authorised representative’ means 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;’

In short, we are the manufacturers legal point of contact within the EU for users of the Medical Devices and the local competent authorities and act on their behalf within the context of the mandate. 

Do I need an EU Authorised Representative for my Medical products? 

Without an EU Authorised Representative in place, it is not possible for a Medical Device Manufacturer located outside the EU to register their Medical Devices or IVD on the EUDAMED (EUropean DAtabase on MEdical Devices). The EU Authorised Representative is involved directly with approvals in the registration process and their details will appear on the Declaration of Conformity (DoC) for the Medical Device(s). A correct and complete DoC, and device registration, will be required to permit sale of a Medical Device within the European Single Market.

What are the responsibilities of an Authorised Representative in the EU? 

The responsibilities of an EU Authorised Representative are conformed by the manufacturer via a written mandate. The mandate shall enable the Authorised Representative to perform the following minimum tasks:

• • Checking Technical Documentation (CE / UKCA Declaration of Conformity and the supporting Technical File) to ensure the requirements of the MDR or IVDR have been met and when necessary, supporting the creation of additional documentation. 
  • Retention of Technical Documentation within the EU for the applicable time period to ensure that it is at the disposal of the Competent Authorities, if requested. 
  • Ensure that the device have been formally registered on the applicable systems / databases i.e. EUDAMED (EUropean DAtabase on MEdical Devices)
  • Cooperation with the Competent Authorities on behalf of Manufacturers when required.  

How do I appoint an EU Authorised Representative?  

Once a manufacturer has done their due diligence and have decided to work with an Authorised Representative, they need to formally instruct the Authorised Representative to perform the necessary tasks in relation to their medical devices. This instruction is provided in the form of a formal written mandate from the manufacturer to the Authorised Representative.

To try and make this part of the process as simple as possible, Eurolink Europe are happy to assist with the mandate by providing a draft standard format that the manufacturer can then use as the basis for their document. Once the mandate has been reviewed and agreed by both parties, the manufacturer and Authorised Representative then sign the document to complete the process.

Why choose Eurolink as your EU Authorised Representative?  

Eurolink Europe has specialised in providing EU Authorised Representative (EUAR) services to Medical Device and IVD manufacturers for over 20 years. As well as the above, our additional services for Medical Device and IVD Manufacturers include: 

• Use of Eurolink Europe company details on product labels and documentation, including Declarations of Conformity.  
• Supporting the registration of Manufacturers, Products and Importers on EUDAMED.   
• Issuing of Declarations of Conformity on behalf of Manufacturers. 
• Review and guidance of product labelling against the requirements of the MDR and the IVDR . 
• Liaison, when required, with other Actors within Device supply chains, such as Importers and Distributors. 
• Delivery of updates on regulatory changes impacting Manufacturers’ devices. 
• Provision of general ad-hoc advisory services when requested. 
• Additional Technical consultancy / CE Marking assistance services as applicable

Fulfilling both the statutory responsibilities of the role of EUAR and providing additional support in the form of Advisory Services, Eurolink Europe has helped dozens of manufacturers ensure they meet the requirements of the MDR and IVDR for hundreds of products.