European Authorized Representative Medical Devices

For medical device manufacturers located outside the EU, regardless of the product category, it is necessary to appoint an authorized representative medical devices established within the EU as their legal entity in the European Union.

What is a european authorized representative Medical Devices?

In accordance with the EU medical device CE certification regulations, including MDD 93/42/EEC, IVDD 98/79/EC and MDR 2017/745/EU, medical device manufacturers established outside the EU must select an agent, distributor or independent authorized representative located within the EU to act as their authorized representative in the European Union.

What are the responsibilities of a European Authorized Representative Medical Devices?

①　As the authorized representative appointed by the manufacturer, liaise with regulatory authorities in various EU countries to handle medical device incidents, complaints, adverse events, recalls and other related work;

②　Maintain the manufacturer’s CE technical documentation, contact the manufacturer, respond and communicate when raised by regulatory authorities, as well as store and update product technical documentation for inspection by competent authorities;

③　Entrusted by the manufacturer, carry out medical device product registration in the EU and apply for the EU Free Sale Certificate;

④　Provide the eu authorized representative identification and its registered address required on product packaging, labels, instructions for use, etc.

What are the consequences of not having a European Authorized Representative?

①　Notified bodies require the appointment of an EC-REP before issuing a medical device ce certificate;

②　Devices placed on the EU market must be marked with the EC-REP on the product packaging;

③　Failure to appoint an EU Authorized Representative may result in the product being detained by customs.

Note: Medical device EU Authorized Representative registration must be handled by a professional organization. Our company has a professional team of engineers and can provide professional services for the export of your products.

Where is the European Authorized Representative indicated on the product?

The European Authorized Representative information must appear on the outer packaging or label of the medical device, as well as in the instructions for use.

Can multiple European Authorized Representatives be selected?

According to MEDDEV 2.5-10, the guideline document for European Authorized Representatives, a company may have multiple authorized representatives, but one and only one European Authorized Representative can be selected for the same product.

Medical Device CE (MDR) Certification Process?

Products exported to the EU such as protective gear, wrist braces, surgical tapes, bandages, band-aids, masks, handrails, reading glasses, wheelchairs, etc., are classified as Class I under the Medical Device Regulation (MDR).

For sterile masks: Classification 1S, requiring involvement of a notified body.

①　Establish the ISO 13485 system; enterprises with existing system certificates shall upgrade the system in consideration of MDR requirements.

②　Establish the UDI system for the product and prepare product technical documentation.

③　Conduct biocompatibility and performance testing of the product.

④　Develop product technical documentation in compliance with MDR requirements for review by the notified body.

⑤　Obtain the CE certificate, and the EU Authorized Representative carries out product registration in Europe.

JJR LAB is familiar with the relevant regulations for European Authorized Representative Medical Devices and can quickly handle the European Authorized Representative service for your medical devices to ensure smooth customs clearance! If you have any questions or need assistance, please feel free to contact us!