Proposed Post-Market Surveillance (PMS) Enhancements UK
Post-Market Surveillance (PMS) Enhancements
Enhanced Reporting Requirements: The proposed PMS regulations will mandate more rigorous and timely reporting of adverse events and other safety-related data from manufacturers. This aims to improve the detection of potential issues with medical devices earlier than present requirements.
Proactive Data Collection: Manufacturers will be required to collect and analyse data proactively from various sources, including user feedback, clinical studies, and real-world evidence. This will help identify trends and potential risks associated with medical devices.
Regular Safety Updates: The regulations will mandate regular updates to the MHRA about the safety and performance of devices. This includes periodic safety update reports (PSURs) which provide a comprehensive overview of the device's safety profile over a specified period.
Transparency and Stakeholder Engagement: The MHRA plans to work closely with stakeholders, including healthcare providers and patient groups, to ensure that the regulations are practical and effectively implemented. Workshops and public consultations will be conducted to gather input and address concerns.
Core Regulations Enhancements
Scope and Classification: The core regulations will redefine the scope and classification of medical devices to align with international standards. This includes clearer definitions and categories for different types of devices, which helps in determining the regulatory pathway for each product.
Requirements for Economic Operators: The new regulations will specify the responsibilities and requirements for economic operators, including manufacturers, importers, and distributors. This ensures that all parties involved in the supply chain are accountable for the safety and compliance of medical devices.
Quality Management Systems (QMS): Enhanced requirements for quality management systems will be introduced, emphasising the need for robust processes and documentation to ensure the consistent production of safe and effective medical devices. This includes compliance with standards like ISO 13485.
International Recognition: The regulations will introduce a framework for the recognition of devices approved by other stringent regulatory authorities, such as the FDA. This aims to streamline the approval process for devices that have already undergone rigorous assessment elsewhere, provided they comply with UK PMS requirements.
Clinical Investigations and Best Practices: Updates to the requirements for clinical investigations will be made, ensuring that they follow best practices and generate high-quality evidence to support the safety and efficacy of medical devices. This includes alignment with international clinical standards and guidelines.