Medical Esthetic can act as an official authorized representative in the EU and actively support the manufacturer in meeting European legal obligations.

What is the function of the EU Authorized Representative?

A manufacturer based outside the European Union is required to designate an authorized representative within the EU. The representative, acting on behalf of the manufacturer, assumes responsibility for medical devices introduced to the European market.

This entity becomes the focal point for the obligations outlined in the legal requirements for medical devices as addressed by the authorities and institutions of the Member States. Additionally, an authorized representative may conduct a conformity assessment of a medical device on behalf of the manufacturer.

As a contract research organization, we offer the following services:

Medical Esthetic can act as an official authorized representative in the EU and actively support the manufacturer in meeting European legal obligations.
Preparation of technical documentation for medical device manufacturing companies: product description, labeling, instructions for use, general safety and performance requirements (GSPR), clinical evaluation, risk management, post-marketing surveillance (PMS) and more.
Initiating a market launch under the umbrella of MDR (Medical Device Regulation (EU) 2017/745): justification of objectives, risks, quality management requirements, medical device safety report under Article 86 MDR which must be updated regularly (annually for class IIb and III devices), and other requirements.
Assistance in product certification (selection and application to a notified body, preparation of documentation, audit and revision of technical documentation).
Simplification of medical device registration.
Clinical trials: clinical trial plan, administrative and organizational support for its approval by the ethics committee, report preparation.
Clinical trials of medical devices on the European market under the rule of MDR (Reglament (EU) 2017/745 about medical devices).
Supporting activities to ensure device safety such as Field Safety Corrective Action (FSCA).
Post-Marketing surveillance (PMS). 
Assistance in obtaining free sale certification.
Assistance in planning the production of a new cosmetic product, preparation of technical documentation, product registration.

Who designates the EU Authorized Representative?

A manufacturer established outside the European Union is required to designate an Authorized Representative.

What are the duties of an authorized EU representative?

Apart from the previously mentioned responsibility to engage with the authorities and institutions of the Member States, including supervisory bodies, the authorized representative has the obligation to:

  • Maintain the technical documentation or the declaration of conformity accessible for inspection by the authorities of the Member States upon request.
  • Ensure accurate product labeling.
  • Respond in the event of a medical incident.
  • Register the product with the relevant office.
  • Participate in safety corrective actions (FSCA).

How to select an independent authorized representative:

The authorized representative should be an independent organization collaborating closely with the manufacturer. While your distribution network may include multiple distributors with expertise primarily in sales and marketing rather than legal requirements, appointing a distributor as an authorized representative may pose challenges in addressing distribution system issues and associated legal requirements. When considering a distributor for this role, take the following into account:

  • Ensure that the authorized representative has access to comprehensive technical documentation, including project-related information.
  • The authorized representative should stay informed about any changes in legal regulations and provide advance warning to your company about such changes.
  • The authorized representative should be capable of effectively representing the manufacturer and addressing inquiries from Competent Authorities regarding the manufacturer’s medical devices.
  • Include the authorized representative’s designation in all information materials, such as labels, packaging, and instructions for use.