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"Responsible Person" in the context of medical devices primarily pertains to the regulatory framework established by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. The Responsible Person is a crucial role outlined in the UK Medical Devices Regulations 2002 (amended in 2009) and more recently in the Medical Devices Regulations 2020, which implement the European Union Medical Device Regulation (MDR) in the UK. The role of the Responsible Person involves various key responsibilities, including: Product Registration and Compliance: The Responsible Person is responsible for ensuring that the medical devices placed on the UK market comply with the applicable regulations. This includes registering the devices with the MHRA and maintaining relevant documentation. Post-Market Surveillance: Monitoring the performance of medical devices on the market and taking appropriate actions, such as recalls or corrective measures, in case of safety concerns. Communication with Competent Authorities: Serving as the primary point of contact between the manufacturer and the MHRA, particularly in matters related to device safety and regulatory compliance. Record Keeping: Maintaining records of the devices placed on the market, including details of distributors, complaints, non-conforming products, and any corrective actions taken. Labeling and Instructions for Use: Ensuring that the labeling and instructions for use of medical devices comply with regulatory requirements and are clear and accurate. Cooperation with Economic Operators: Collaborating with other economic operators in the supply chain, such as manufacturers, importers, and distributors, to facilitate regulatory compliance. It's essential to stay updated on any changes in regulations and guidelines, as the responsibilities of the Responsible Person may be subject to updates and amendments. The MHRA website and relevant regulatory documents are valuable resources for the most current information on this role and associated obligations. 🌐 *Connect With Us:* https://patientguard.com If you are looking for Quality Assurance Templates to help you with your Quality Management System then head over to: https://qmsregs.com #mhra #medicaldevices #medicaldeviceregulations #patientsafety