The European Authorized Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep / EC Rep, the manufacturer must sign a contract outlining each party’s rights and responsibilities, as well as the general way of collaboration and costs.

According to the EU MDR 2017/745 and EU IVDR 2017/746, EU Representative is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the European market. The European Authorized Representative is a natural or one that is legalized and established within the EU, who has received and accepted a written mandate or decree from the manufacturer located outside of the European Union.

This can be a great way for international companies to sell their products in Europe, as it helps streamline the process of getting your product approved for sale by European regulators.

Responsibilities of EU Representative

According to Article II of the EU MDR and IVDR, the following are the roles and responsibilities of the European Authorized Representative.

• Provide a registered address in the EU to be mentioned on the product packaging
• Keep the updated Technical File documentation available for inspection by the competent authorities
• Represent the manufacturer in front of the European Commission, NB’s and the users
• Device registration and EU Free Sale Certificates
• Take care of incidents reported by the healthcare professionals, patients, and users
• Safeguard the compliance with regulatory news and updates
• Check the registration of the importer, manufacturer with the EU and update accordingly
• EU Representative consult and continuously support the manufacturer
• Terminate the mandate if the manufacturer acts contrary to MDR/IVDR obligations
• Review and guide on PMS, PMCF and PSUR requirements, if required

Benefits of working with I3CGLOBAL and its associates

• ISO 27001:2013 Certified data security system. We safeguard the confidentiality of technical documents and other information you provide to us.

• When judgments must be made that go against the interests of an importer/distributor, we operate in your best interests.

• While distributors and corporate branch offices may have other priorities, we react to inquiries from authorities quickly and effectively.

• Unlike other legal firms and trading organizations, we are regulatory consultants for medical devices. We provide quality and compliance knowledge in countries outside of the EU, such as the United Kingdom and the United States, ensuring that manufacturers obtain good value for money throughout the EAR process and other significant markets.

Whether you need a company to carry out regulatory matters, market in your territory, or provide new kinds of expertise or technical advantage, we'll be there for you. With I3CGLOBAL as your partner, you can expect us to be responsive to your needs at all times.