Spain | HEADQUARTER

Your Authorized Representative in Europe

We act as your Authorized Representative in the EU, ensuring that your medical devices comply with all European regulations, facilitating smooth and efficient market entry.

As the main headquarters of CMC MEDICAL CONSULTING GROUP, CMC DEVICES & DRUGS SL acts as an “Authorized Representative” for manufacturers without a registered office in the European Community, fulfilling specific obligations under relevant EU legislation.

CMC Medical Devices & Drugs S.L., a member of the EU Authorized Representatives Association (EAAR), is qualified and serves as one of the EU’s authorized representative companies with a broad global client base.

We can also serve as your legal representative in the EU for clinical trials of medical devices and/or In Vitro Diagnostic Devices.

Legal Representative (EU MDR / IVDR)

CMC can act as your Legal Representative in the European Union for clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices, in accordance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

As your Legal Representative, CMC serves as the official liaison between the sponsor/manufacturer and the European competent authorities and ethics committees. We support compliance with all applicable regulatory, legal, and documentation requirements throughout the clinical trial or performance study lifecycle.

Our services ensure effective regulatory oversight, clear communication with authorities, and full alignment with European regulatory frameworks, enabling your clinical activities in the EU to be conducted safely, efficiently, and in compliance with MDR and IVDR requirements.

Our functions as a Legal Representative

As Legal Representative under EU MDR and IVDR, CMC assumes the following responsibilities in relation to clinical investigations and performance studies:

  • Act as the official point of contact between the sponsor/manufacturer and European competent authorities and ethics committees.
  • Ensure regulatory compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) for clinical investigations and performance studies.
  • Verify that the clinical investigation or performance study documentation is complete, accurate, and available to authorities upon request.

  • Support submission, notification, and communication procedures with competent authorities in the EU.

  • Maintain availability of essential regulatory documentation for inspection by competent authorities.
  • Assist in the reporting of serious adverse events and device deficiencies, in coordination with the sponsor.
  • Facilitate regulatory inspections and audits related to the clinical investigation or performance study.

Support compliance with post-study obligations, including reporting and documentation retention requirements.

Legal Importer for Medical Devices & IVD Products in Europe

CMC Medical Devices can act as your legal importer in Europe for medical devices and IVD products, ensuring compliance with European import regulations and simplifying market entry.

We handle all necessary documentation, customs procedures, and regulatory requirements, allowing your products to be imported smoothly, legally, and efficiently.

With CMC as your legal importer, you can focus on your business while ensuring regulatory compliance and secure market access in Europe.

Physical Importation of Medical Devices & IVD Products into Spain

CMC Medical Devices holds a valid import license for medical devices and in vitro diagnostic (IVD) products.

We can manage the import process, ensure compliance with local regulations, and facilitate the import of products into the market. This enables distributors and manufacturers to access the market efficiently and safely in Spain.

With CMC, you can import medical devices and IVD products efficiently and in full compliance with regulations.

Product Registration

Our service includes the registration of medical devices and/or in vitro diagnostic products with the competent authorities in Spain (AEMPS) before placing them on the market.

Once the registration is completed, manufacturers can export their products to the EU market.

Select CMC as
Your Authorized Representative in Europe

Complete the contact form and one of our consultants will get in touch as soon as possible.

    Why appoint CMC Medical Devices?

    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.