If you are a Medical Device or In-Vitro Diagnostic Device (IVD) manufacturer without a registered office in the EU, you must appoint a local European Union Authorized Representative to meet the requirements of The Regulations on Medical Devices (Regulation (EU) 2017/745, aka the MDR) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746, aka the IVDR).

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

Without an Authorised Representative in place, it is not possible for a Manufacturer located outside the EU to register their Medical Devices or IVD for sale or use within the European Single Market.

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

• Checking Technical Documentation 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 to ensure that it is at the disposal of the Competent Authorities if requested. 
• Cooperation with the Competent Authorities on behalf of Manufacturers when required.  

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.