What is an EU Authorized Representative?
Under the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746, medical device manufacturers located outside the European Union must appoint an EU Authorized Representative (AR) to sell their devices on the EU market. This is not a new requirement, though the regulations expanded compliance requirements for ARs and increased their legal liability. The AR acts as a legal representative for manufacturers, serving as a point of contact for EU Competent Authorities and Notified Bodies, and is responsible for ensuring the device’s compliance with regulatory requirements. This role is symbolized through an EC Representative logo (EC REP) as a mandatory symbol. They must also register in EUDAMED.
The Role of your Authorized Representative
Your AR performs essential responsibilities in the pre- and post-market stages of CE Marking. ARs are legally liable on the same basis as manufacturers for defective medical devices if the manufacturer has not complied with regulatory requirements. As such, ARs are responsible for ensuring your Technical Documentation meets the requirements of MDR/IVDR and is up to date (in conformity to applicable regulations). They will also act as the contact point for EU authorities and keep a copy of your Technical Documentation on file to supply to NBs or Competent Authorities on request. The AR’s details also appear on your device’s labeling and packaging.
After your device is CE Marked and placed on the market, your AR assists with ongoing compliance, helping to address any complaints or incidents, and liaises with regulators to support field safety corrective actions (FSCAs) and recalls.
How to choose an EU Authorized Representative for MDR and IVDR compliance
Choosing the right AR is crucial to successful market entry in the EU, as well as minimizing legal and regulatory risks for your company. The AR is the legal entity, and you must sign a written mandate that outlines the AR’s obligations. At the very least, your AR must be an individual or company with a physical address in an EU Member State. Make sure your AR fulfills the criteria in Articles 11, 12 and 15 of the MDR and IVDR. MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - October 2022 is another useful tool to understand the scope of the AR role. If your AR does not maintain compliance with their regulatory obligations, it can compromise your compliance as well.
In addition to these minimum requirements, your AR should have in-depth knowledge of the MDR/IVDR and experience handling regulatory submissions, particularly in your device category. They should also have the resources and personnel to respond quickly to compliance issues and EU authority communications. For these reasons the AR, similar to the manufacturer, has to appoint a Person Responsible for Regulatory Compliance (PRRC), which must be permanently and continuously at their disposal.
