European Authorized Representative (EC REP)

CMC Medical Devices offers European Authorized Representative for Medical Device

For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) require that manufacturers outside the EU designate an european authorized representative based within the EU. This representative is crucial in ensuring the compliance of these devices and serves as the main contact point within the EU.

European Authorized Representative

We can help you

It refers to a natural or legal person explicitly designated by a manufacturer located outside the European Economic Area. The natural or legal person can perform specific tasks required by the relevant EU directives and laws on behalf of the manufacturer outside the EEA.

Spain is a member of the European Union (EU) and is within the European Economic Area (EEA).

CMC Medical Devices & Drugs SL, located in Spain, is a member of the European Association of Authorized Representatives (E.A.A.R). It has a professional regulatory team and is qualified to act as an authorized representative for manufacturers outside the EU. CMC maintains close communication and cooperation with authorities and can perform the corresponding tasks for manufacturers according to official instructions.

Our functions as a EU Authorized Representative

Registers your devices with the relevant national authorities before commercialization, when applicable.
Acts as your main point of contact for all national competent authorities.
Maintains an updated copy of your technical file available for inspection by the European competent authorities.
Authorizes you to place our name and address on the labels, packaging, and instructions for use of your device.
Always available to interact between you and the National Competent Authorities.
Responsible for reporting incidents and Field Safety Corrective Actions (FSCA) to the competent authorities, in cooperation with you and your distributors.

Protects the confidentiality of your documentation. The European Authorized Representative may only show technical documentation to Competent Authorities as required by law.
Monitors changes in regulations and communicates with you only when applicable.
Represents you before the European Commission for consultations in case of withdrawal of a medical device by one or more Member States.
Maintains reports related to the critical assessment of all data collected during clinical evaluations for review by Competent Authorities.
Notifies or is notified by Competent Authorities about serious device incidents or Field Safety Corrective Actions (FSCA).
Post-market surveillance.

Select CMC as your EU Authorised Representative (EC REP)

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Frequently asked questions about EC representative

Why do you need an EC REP?

Manufacturers based outside the EU are legally obliged to appoint an Authorized Representative (EC REP) so that their products can legally circulate within the European Union market.

Regardless of whether a medical device requires the intervention of a Notified Body (in the case of Class I sterile/measuring/reusable, IIa, IIb and III) to obtain CE Marking, or whether the manufacturer can self-certify (Class I simple), those operating outside the EU must appoint an Authorized Representative so that their products can be placed on the European market.

The Authorized Representative plays a crucial role in ensuring device compliance, acting as the point of contact within the Union. The Authorized Representative’s minimum responsibilities include:

● Verifying that the technical documentation and other essential documents have been prepared and that the manufacturer has fulfilled its registration obligations.

● Providing the competent authority with all information and documentation necessary to demonstrate the conformity of a device.

● Transmit to the manufacturer any request from the competent authority to obtain samples of the device.

● Collaborate with the competent authorities in any preventive or corrective actions aimed at eliminating or mitigating risks that devices may present.

● Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about possible incidents related to a device for which they have been designated.

The European Authorized Representative (EC-REP or EAR) shares responsibility in case of defective products and is obliged to terminate the contract with the manufacturer if the manufacturer acts inconsistently with its obligations. Therefore, the EAR is responsible for defective products when the manufacturer has not fulfilled its obligations under the Medical Device Regulation (MDR).

How support you?

For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) mandate that non-EU manufacturers appoint an authorized representative based in the EU. This representative is crucial for ensuring compliance and acts as a primary contact point within the EU.

Since 2014, CMC Medical Devices has been dedicated to providing representation and consultancy services to manufacturers seeking entry into the EU market. Our headquarters, located in Spain, places us strategically to work closely with EU institutions. We are actively involved in European Commission Working Groups and Horizon Europe, the EU’s research and innovation program, shaping the compliance landscape over the years.
CMC Medical Devices is also a member of the European Association of Authorised Representatives (EAAR) and a founding member of the European Responsible Person Association (ERPA), both organizations committed to maintaining high standards of service and professionalism.
We highly recommend choosing a professional representative for your company within the EU. CMC Medical Devices offers:

● A team of experts to guide you through the compliance process
● Confidential handling of all shared information
● No conflict of interest, as we do not engage in manufacturing or selling products
● Up-to-date information on regulatory changes

Since our establishment, CMC Medical Devices has grown significantly and is a reference company in Europe for regulatory compliance. Our experts are well-equipped to help you navigate the EU, UK, and Swiss markets.

Why appoint CMC Medical Devices as you EC-REP?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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