EU Authorized Representative Medical Device

For medical device manufacturers located outside the European Union, regardless of the product class, it is required to appoint an eu authorized representative to act as their legal entity within the EU.

What is an EU Authorized Representative for Medical Devices?

According to the EU medical device CE certification regulatory documents MDD 93/42/EEC, IVDD 98/79/EC, and MDR 2017/745/EU, medical device manufacturers located outside the EU must select an agent, distributor, or an independent authorized representative based within the EU to serve as their EU Authorized Representative (EC-REP).

What are the Responsibilities of an EU Authorized Representative?

• Regulatory Communication: Act as the authorized representative designated by the manufacturer to communicate with regulatory authorities across EU member states and handle medical device accidents, complaints, adverse events, and product recalls.

• Technical Documentation Management: Retain the manufacturer's CE technical documentation. When regulatory authorities raise inquiries, the representative must contact the manufacturer, facilitate replies and communication, as well as maintain and update product technical files for review by competent authorities.

• Product Registration: Under the entrustment of the manufacturer, register medical device products in the EU and apply for the Free Sale Certificate (FSC) issued by the EU.

• Labeling Compliance: Provide the required EU Authorized Representative logo and registered address for product packaging, labeling, and instructions for use.

What are the Consequences of Not Having an EU Authorized Representative?

• Certification Block: Notified Bodies require the designation of an EC-REP before they can issue a medical device ce certificate.

• Market Entry Refusal: For devices placed on the EU market, the EC-REP information must be explicitly marked on the product packaging.

• Customs Detention: If an EU Authorized Representative is not appointed, the products run a high risk of being detained by customs.

Note: The registration of an EU Authorized Representative for medical devices must be handled by a professional agency. Our company has a team of expert engineers who can provide professional services to ensure the smooth export of your products.

Where is the EU Authorized Representative Displayed on the Product?

The EU Authorized Representative's information must appear on the outer packaging, the product labels, and within the instructions for use (IFU) of the medical device.

Can Multiple EU Authorized Representatives Be Selected?

According to the EU Authorized Representative guidance document MEDDEV 2.5/10, a company may have multiple authorized representatives; however, each specific product can and must have only one EU Authorized Representative.

What is the Medical Device CE (MDR) Certification Process?

1. Product Classification: Products such as protective gear, wristbands, surgical tapes, bandages, Band-Aids, masks, handrails, reading glasses, and wheelchairs exported to the EU are classified as Class I according to the Medical Device Regulation (MDR).

2. Notified Body Involvement (If Applicable): For sterile products like sterile masks, they are classified as Class Is, which strictly requires the intervention of a Notified Body.

3. Quality Management System (QMS): Establish an ISO 13485 quality management system. Enterprises that already hold system certificates must upgrade their systems to fully comply with MDR requirements.

4. UDI & Documentation Preparation: Establish the Unique Device Identification (UDI) system for the product and begin preparing the product's technical documentation.

5. Testing: Conduct necessary biocompatibility and performance testing for the product.

6. Documentation Review: Compile complete product technical documentation compliant with MDR requirements for the Notified Body to audit.

7. Certification & Registration: After obtaining the CE certificate, the EU Authorized Representative will proceed with the final product registration in Europe.