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EU Authorised Representation

Located in Northern Ireland, we can act as an EC-REP for medical device & IVD Manufacturers

The Role of a European Authorised Representative (EU AR)

A European Authorised Representative (EU AR) is an entity within the EU authorised to act on behalf of a manufacturer based outside the EU.
This relationship, governed by a written mandate, enables the EU AR to represent the manufacturer in compliance with the Medical Devices Regulation (MDR) 2017/745. Manufacturers outside the EU must appoint an EU AR to legally sell medical devices and IVDs in the European market.

The EU AR serves as the manufacturer’s regulatory liaison within the European Single Market and communicates with the National Competent Authorities. The EU AR also shares liability with the manufacturer for products marketed in the EU.

Responsibilities of the EU Authorised Representative
Pre-Market Responsibilities

• Verify that the manufacturer’s technical documentation aligns with the appropriate conformity procedure and ensure CE marking compliance.

• Maintain copies of the technical file and CE marking certificate for each device.

• Authorise the inclusion of the EU AR’s name and address on the manufacturer’s device labelling and relevant documentation.

• Establish a formal agreement (mandate) detailing the obligations of both the manufacturer and the EU AR throughout the product’s lifecycle in the EU market.

Ongoing Responsibilities

• Review and verify the manufacturer’s EUDAMED Single Registration Number (SRN) application, ensuring compliance with Competent Authority requirements.

• Ensure the manufacturer meets all registration obligations.

• Maintain technical documentation for a minimum of 10 years after the device’s market introduction (15 years for implantable devices).

• Provide copies of technical documentation or EU Declaration of Conformity to Competent Authorities upon request.

• Inform the manufacturer of complaints from healthcare professionals, users, and patients, and support incident reporting and Field Safety Corrective Actions (FSCA) in cooperation with the manufacturer and distributors.

Why Choose Clonallon Laboratories as Your EU AR and UKRP?

Clonallon Laboratories provides unparalleled value as your EU Authorised Representative and UK Responsible Person (UKRP). Strategically located in Northern Ireland, Clonallon is uniquely positioned to offer manufacturers seamless access to both the EU and UK markets.

By choosing Clonallon, you gain a trusted partner dedicated to ensuring your success in these highly regulated regions. Here’s why Clonallon is the right choice:

• Dual Market Access: Northern Ireland’s unique position within both the EU Single Market for goods and the UK market ensures streamlined compliance and distribution for your products

• Expansive Market Reach: Partnering with Clonallon opens the doors to over 450 million consumers across the EU and an additional 67 million in the UK, offering tremendous growth opportunities for your business.

• Regulatory Expertise: Clonallon’s deep knowledge of MDR, IVDR, and UK regulatory frameworks guarantees that your devices meet all necessary requirements.

• Proactive Support: From EUDAMED registration to technical documentation preparation, Clonallon offers end-to-end support to get your products to market quickly and efficiently.

• Minimised Risks: With Clonallon sharing liability and actively monitoring regulatory changes, you can focus on your core business with confidence.

• Efficient Problem Resolution: Clonallon’s experienced team handles complaints, incident reporting, and field safety corrective actions promptly, reducing potential disruptions.

• Simplified Global Expansion: Assistance in obtaining Certificates of Free Sale (CFS) and navigating export requirements ensures your devices can reach global markets with ease.

• Tailored Services: Clonallon works closely with each manufacturer, offering customised solutions to meet your unique regulatory and business needs.

By selecting Clonallon Laboratories as your EU AR and UKRP, you position your company for success with a partner committed to optimising compliance, reducing delays, and maximising your market potential.

Labelling Requirements for the EU AR

Under the MDR 2017/745, the EU AR’s name and address must be displayed on the device label. While not mandatory for inclusion in the Instructions for Use (IFU), adding this information improves traceability, particularly if packaging is discarded.

To minimise translation needs, the EU AR’s details should appear alongside the EC REP symbol, as specified in EN ISO 15223-1:2016. For small device labels, the information can be placed on unit or bulk packaging. Additionally, the EU AR is listed in the Declaration of Conformity and, where applicable, in the Notified Body CE Marking Certificate.

Transferring an EU Authorised Representative

Under MDR 2017/745 Article 12, manufacturers may change their EU AR by following these steps:

• Label Updates: Revise product labelling to reflect the new EU AR’s details.

• Transition Planning: Define clear start and end dates for the old and new EU ARs, updating documentation accordingly.

• Complaint Handling: Ensure the previous EU AR transfers all complaints related to pre-transition devices.

• Formal Agreement: Where possible, document transition details in an agreement among all parties involved.

To minimise costs and delays, manufacturers should carefully select a reliable and experienced EU AR service provider. Clonallon Laboratories offers trusted expertise, a strategic presence, and a proven track record, making them the ideal partner for market expansion and compliance across Europe and the UK.