Representation | legal representative

Your legal representative in clinical trials

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).

Legal Representative (EU MDR / 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.

Select CMC as Your Legal Representative in Clinical Trials

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    Frequently asked questions about Legal Representative in Clinical Trials

    Acting as a Legal Representative in clinical trials means overseeing and ensuring compliance with legal and ethical regulations throughout the trial process. This role is crucial for maintaining safety, credibility, and the integrity of trial results. The Legal Representative ensures that all aspects of the trial adhere to regulatory standards and that participants’ rights and well-being are protected.

    A Legal Representative plays a vital role in clinical trials by ensuring adherence to legal and ethical standards. Their responsibilities include overseeing compliance with regulatory requirements, managing documentation, and ensuring the trial’s safety and credibility. Their involvement helps maintain the integrity of the trial results and protects the rights and safety of participants.

    As a Legal Representative in clinical trials, CMC Medical Devices offers several key services:
    ○ Ensuring compliance with all applicable legal and ethical regulations.
    ○ Overseeing the safety and well-being of trial participants.
    ○ Managing and verifying trial documentation and reports.
    ○ Acting as a liaison between the trial sponsors and regulatory authorities.
    ○ Ensuring that the trial’s outcomes are credible and in line with regulatory standards.

    CMC Medical Devices ensures the safety and credibility of clinical trials by adhering to strict legal and ethical guidelines. This includes conducting thorough reviews of trial protocols, ensuring proper informed consent procedures, monitoring trial progress, and managing any issues that arise to ensure that the trial results are reliable and participants are protected.

    Yes, CMC Medical Devices can serve as your Legal Representative in the EU for clinical trials involving medical devices and/or In Vitro Diagnostic devices. We provide comprehensive support to ensure that your trials comply with EU regulations and standards, facilitating a smooth and compliant trial process.

    Manufacturers can access various resources to assist with PPE compliance, including information platforms that provide up-to-date details on European legislation. These resources help manufacturers stay informed and ensure their products meet the latest regulatory requirements

    Clinical trials are governed by various legal and ethical regulations that include requirements for participant safety, informed consent, and trial conduct. These regulations are designed to protect participants’ rights and ensure the validity of trial results. Compliance with these regulations is critical to conducting ethical and credible research.

    Professional legal representation services for medical device manufacturers

    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.