For manufacturers outside the European Union, entering the EU market with medical devices or in vitro diagnostics (IVDs) means complying with strict regulations. A key requirement under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) is the appointment of a European Authorised Representative (EU AR).
Why Do You Need an EU Authorised Representative?
Article 11 of the EU MDR and IVDR mandates that non-EU manufacturers wanting to sell their product on the European market must either have a physical presence in the EU or appoint an EU AR to represent them to European authorities. The EU AR acts as your regulatory liaison, bridging the gap between your company and the European National Competent Authorities (NCAs). Additionally, the EU AR’s name and address need to be stated on your product labelling.
Without an EU AR, your products cannot legally be sold in the European market. Beyond compliance, an EU AR provides essential support throughout your product’s lifecycle, ensuring smooth market access and regulatory adherence.
Key Responsibilities of an EU AR
Your EU AR’s role goes far beyond registration. They are a critical partner in ensuring your product’s success in the EU, covering:
- Liaising with Competent Authorities.
- Reviewing technical documentation review, to verify it complies with MDR/IVDR requirements.
- Ensuring the device is appropriately CE-marked and maintaining a copy of the CE certificate.
- Assisting with the manufacturer’s Single Registration Number (SRN) application and ensuring compliance with EUDAMED obligations.
- Retaining the technical documentation and CE certificate for 10 years (non-implantable devices) or 15 years (implantable devices).
- Providing technical documentation or the EU Declaration of Conformity upon request from Competent Authorities.
- Inform manufacturers of complaints from users, healthcare professionals, and patients.
- Supporting manufacturers in incident reporting and Field Safety Corrective Actions (FSCA) in collaboration with importers and distributors.
- Have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance (PRRC) – Art.15.
Selecting the Right EU Authorised Representative
Choosing the right EU AR is a pivotal business decision. Many distributors or importers act as EU ARs, but these arrangements often come with conflicts of interest. For example, a distributor serving as your EU AR may limit your ability to work with other partners, potentially narrowing your market access. Working with an independent team of knowledgeable regulatory professionals on the other hand, offers an unbiased approach that prioritises your success.
Complying with MDR/IVDR is no small feat, but with the right EU AR, your pathway to the European market can be streamlined and efficient.
Visit our website to discover how IMED Consultancy’s proven international medical regulatory experience can help you stay ahead of new regulations and EU AR requirements!