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Authorized Representative for Medical Devices in the European Union

Experts in European Regulation 2017/745 (MDR)

We act as Authorized Representatives of cosmetic products in the EU, we prepare the documentation for their subsequent registration and we advise you in the process of obtaining the CE marking.

Regulatory and Compliance for Medical Devices in the European Union

European Regulation 2017/745 (MDR)

According to the new MDR Regulation, all medical devices must obtain the CE mark by undergoing a new and complete Conformity Assessment following the deadlines stipulated by the regulation.

For a successful transition from MDD to MDR, a combination of different key aspects is crucial:

  • In-depth knowledge of the legislation.

  • Have a Technical Product Dossier (Technical File) in accordance with the legislation.

  • Have an Authorized Representative in Europe in the case of products from foreign companies (from outside the EU).

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What is the role of the authorized representative in the EU?

​For manufacturers established outside the European Union (EU) wishing to place their medical devices on the EU market, it is essential to appoint an authorized EU representative. This representative replaces the manufacturer in the EU regulatory framework.

Their main responsibilities are to ensure that medical devices comply with EU standards and regulations.

It is the main point of contact with the authorities of the EU Member States for any obligation or query related to medical devices.

In some cases, the authorized representative may be responsible for assessing the product's conformity with EU requirements on behalf of the manufacturer.

Functions of the MD EU-REP

  • Creation and validation of product technical sheets

  • Provision of technical records for regulatory audits

  • Help in obtaining product certifications

  • Facilitate product registration processes

  • Support tasks related to device security, including reporting of medical incidents.

Who appoints the EU authorized representative?

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

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Duties and obligations of an authorized EU representative

Authorized representative

An EU Authorized Representative plays a key role in ensuring compliance and proper representation of a medical device manufacturer on the European market. Here's a concise breakdown of your main responsibilities:

  1. Documentation management: The authorized representative must maintain the product's technical documentation or declaration of conformity. In this way, you can present it without delay to the authorities of any Member State that request it.

  2. Labeling supervision: They are responsible for verifying and ensuring that product labeling is accurate and complies with EU regulations.

  3. Incident Response: In the event of a medical incident involving the product, the authorized representative must act quickly and appropriately.

  4. Product registration: They are responsible for registering the product with the corresponding EU regulatory office.

  5. Safety measures: Participation in safety corrective measures, often abbreviated as FSCA, also falls within its remit.

Selecting a Trusted Independent Authorized Representative

Choosing the right authorized representative is crucial for smooth operation and regulatory compliance.

Here are some considerations:

  • Opt for an independent entity that aligns with the manufacturer's goals.

  • Ensure the representative has access to comprehensive technical documentation, offering a holistic view of the product.

  • The chosen entity must stay up to date with evolving legal regulations, proactively notifying the manufacturer of any impending changes.

  • Must possess the knowledge necessary to respond to regulatory inquiries regarding the manufacturer's products.

  • Its representation must be consistent in all materials related to the product, from labels to user manuals.

Obligations in the EUDAMED database

The future EUDAMED database will be a key piece for economic operators, including authorized representatives.

This is what it means to them:

  • Once EUDAMED is fully operational, authorized representatives will need to register in this electronic system.

  • Each representative who meets the obligations of the MDR will be assigned a Unique Registration Number (SRN), which will ensure traceability and credibility.

  • This registry ensures transparency, as the public can verify the data of any authorized representative in the database.

In essence, the EU authorized representative acts as a bridge between the manufacturer and the regulatory framework of the European market, ensuring that products meet strict standards and all legal requirements.

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