Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
An EU Authorised Representative (EAR) is a natural or legal person established in the EU, appointed in writing by a manufacturer outside the EU, to act on its behalf for specified tasks under MDR (EU) 2017/745 Article 11 or IVDR (EU) 2017/746 Article 11.
If your company is established outside the EU and you place a device in scope of MDR or IVDR on the EU market, you must appoint an Authorised Representative established in the Union before that device can be placed on the market. The Authorised Representative holds a written mandate, verifies your declaration of conformity and technical documentation have been prepared, keeps documentation available to national authorities, cooperates with authorities on corrective action, and is registered with EUDAMED as an economic operator alongside you. Its name and address appear on the device label or accompanying documentation.
The Authorised Representative does not take on the manufacturer's core compliance obligations - device safety, performance and conformity remain the manufacturer's responsibility.
A manufacturer outside the EU needs its own PRRC (Article 15(1)); micro and small enterprises may instead have one permanently and continuously at their disposal (Article 15(2)). The Authorised Representative must separately have its own PRRC (Article 15(6)). Under MDCG 2019-7 these cannot be the same person, and for micro and small enterprises they cannot belong to the same external organisation. Our Authorised Representative service includes our own PRRC under Article 15(6); as an external PRRC we work only for manufacturers represented by another Authorised Representative - see PRRC services.
Under MDR/IVDR Article 11, the Authorised Representative verifies the declaration of conformity and technical documentation have been drawn up, keeps documentation available to authorities, cooperates on corrective action and field safety, registers with EUDAMED and acts as the EU contact point for a non-EU manufacturer.
No. The Authorised Representative acts on the manufacturer's behalf under a written mandate and does not take title to the goods. Importers and distributors have separate obligations and duties under MDR/IVDR.
Yes, if you place a device in scope of MDR or IVDR on the EU market and your company is established outside the EU, you need an Authorised Representative before that device can be placed on the market.
The Authorised Representative is an EU-established economic operator appointed under Article 11. The PRRC (Person Responsible for Regulatory Compliance, Article 15) is a specific qualified role focused on regulatory compliance tasks. The manufacturer and its Authorised Representative each need their own PRRC, and under MDCG 2019-7 the same person cannot fill both roles - so we act as external PRRC only for manufacturers we do not represent.
Yes. The Authorised Representative and the manufacturer it represents must be registered as economic operators in EUDAMED, and the Authorised Representative's details appear on the device labelling and documentation.
Note: This page provides general information, not legal advice. Specific obligations depend on your device classification and company structure.
Tell us your device type, class and where your company is established. Before you sign a mandate, we tell you what the next step is.