Code of Conduct

  1. Promotion of Professional Conduct and Competence:
  • UK Responsible Persons (UKRPs) shall uphold high standards of professional conduct and competence in all aspects of their duties related to medical devices.
  • UKRPs shall continually strive to enhance their knowledge and skills to effectively fulfill their obligations under The Medical Devices Regulations 2002 (SI 2002 No 618) and any other relevant regulatory requirements.
  1. Understanding of Regulatory Requirements:
    • UKRPs shall maintain a comprehensive understanding of the regulatory requirements for medical devices as outlined in The Medical Devices Regulations 2002 and any subsequent amendments or updates.
    • UKRPs shall possess commensurate experience and expertise to ensure compliance with regulatory standards and best practices in the field of medical devices.
  1. Cooperation with Regulatory Authorities:
    • UKRPs shall cooperate closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enhance transparency and understanding of regulatory requirements within the medical device industry.
    • UKRPs shall promptly respond to any requests from the MHRA and provide all necessary information and documentation to demonstrate the conformity of devices as required by regulatory authorities.
  1. Obligations to MHRA:
    • UKRPs shall fulfill all obligations specified by The Medical Devices Regulations 2002, including but not limited to:
      • Registering devices with the MHRA.
      • Ensuring that declaration of conformity and technical documentation are in place and accessible for inspection by the MHRA.
      • Providing samples of devices to the MHRA or facilitating access to devices as requested.
      • Cooperating with the MHRA on any preventive or corrective actions related to medical devices.
      • Immediately informing manufacturers about complaints and incidents related to devices.
      • Terminating legal relationships with manufacturers if they act contrary to regulatory obligations and notifying the MHRA accordingly.
  1. Ethical Conduct:
    • UKRPs shall conduct themselves with integrity, honesty, and transparency in all interactions related to their role as Responsible Persons for medical devices.
    • UKRPs shall prioritize the safety and well-being of patients, healthcare professionals, and users of medical devices in all decision-making processes.
  1. Professional Development:
    • UKRPs shall engage in ongoing professional development activities to stay abreast of advancements in medical device regulations, technologies, and industry standards.
    • UKRPs shall actively seek opportunities for learning and knowledge-sharing to enhance their professional competencies and contribute to the continuous improvement of the medical device sector.

This Code of Conduct serves as a guiding framework for UK Responsible Persons to uphold the high standards of professional conduct and regulatory compliance in their roles within the medical device industry.