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.
Organization of a customs warehouse in the European Union.
Supply chain control to prevent parallel imports and to ensure medical device deliveries comply with EU legislation.

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.
CE marking is a mandatory requirement of the European Union for the introduction of medical devices, personal protective equipment, and in vitro diagnostic medical devices into the European market. The CE marking process ensures conformity with specific directives or regulations, and it can be achieved through a manufacturer’s declaration or by undergoing an assessment by a notified body, depending on the risk class of the product.

Before placing on the market

In order to place a product on the market within the European Union, a number of requirements must be met, which are set out in European directives or regulations. The detailed requirements appear already at the design stage, through production, quality control and product registration.
Verification of Qualification and Classification
Ensuring the accurate qualification and classification of a medical device is vital for determining the appropriate conformity assessment procedure. This precision helps prevent legal complications and minimizes additional costs.
Analysis of Harmonized Standards
The identification and execution of required tests in alignment with harmonized standards enable the evaluation of product effectiveness and safety for use.
Risk Management and Analysis
To bring a product to market, it is essential to identify, assess, and evaluate the associated risks. Additionally, monitoring the effectiveness of the risk management process is crucial.
Clinical trials of medical devices on the EC market in accordance with MRD (Regulation (EU) 2017/745 on medical devices)
Placing medical devices on the market in accordance with MRD (Regulation (EU) 2017/745 on medical devices): justification of objectives, risks, quality management requirements, medical device safety report in accordance with Article 86 of the MDR, which must be updated regularly (annually for Class IIb and III devices), as well as other requirements.
Preparation of Technical Documentation
Thoroughly prepared technical documentation is essential to ensure compliance with the comprehensive safety and performance requirements of the medical device.
Verification of Technical Documentation
Ensuring that the technical documentation aligns with the relevant legal requirements is a crucial step before initiating the certification or notification process.
Selection and Contacting a Notified Body
A critical step involves choosing a notified body that is appropriate for certifying the manufacturer's products based on factors such as classification, specific codes, and conformity assessment procedures.
Product Registration CA | EUDAMED
Before introducing a medical device or in vitro diagnostic medical device to the market, it is necessary to register or notify the pertinent Competent Authority or EUDAMED.
Medical Device Labeling
The labeling of medical devices is a pivotal aspect of regulation and oversight within the European Union, with the primary objective of ensuring patient safety, as well as the effectiveness and quality of medical devices. Labeling assumes a critical role in the conformity assessment process and contributes significantly to the identification and traceability of medical devices in the EU market.

After placing on the market

Following successful completion of the product conformity assessment process, the Manufacturer shall ensure that the surveillance and control activities for the manufacture of the devices, as well as the related post-market surveillance and observation activities, are carried out in a manner consistent with the current legal status.

  • Post-Market Surveillance (PMS)

As a component of market surveillance, it is crucial to establish and routinely update procedures for actively collecting and reviewing the post-marketing experience gained.

  • Vigilance

Vigilance involves the identification of medical incidents and events, as well as the implementation of corrective actions related to device safety.

  • Certificate of Free Sale

The certificate of free sale is a document that streamlines the export of medical devices and in vitro diagnostic medical devices from the European Union to other regions.