Summary:
Today (20- December), the UK has published a new Statutory Instrument "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024"
The Draft Statutory Instrument published in October 2024 has now been made.
These regulations enhance post-market surveillance systems, clarify reporting obligations, and strengthen manufacturers' accountability for devices placed on the market in Great Britain.
Key Updates:
Updates definitions that will apply for the purposes of post-market surveillance (PMS).
Manufacturers must establish a post-market surveillance system, which should be based on a PMS plan.
PMS Reports (PMSR) required for low-risk devices and updated every three years.
Periodic Safety Update Reports (PSURs) required for medium and high-risk devices (updated every two years or annually for high-risk devices)
Manufacturers must retain PMS documentation for at least 10 years after the last device is placed on the market (15 years for implantable devices).
The PMS Regulations come into force 6 months from the day the regulations were made.
Explanation of the MHRA Post-Market Surveillance (PMS) Requirements
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduces new requirements for post-market surveillance (MHRA PMS) for medical devices in Great Britain. These amendments align with the UK’s regulatory framework under the Medical Devices Regulations 2002 and provide comprehensive oversight of the safety and performance of medical devices after they enter the market.
Key Highlights of the Regulations
Purpose and Scope:
Applies to all medical devices and accessories placed on the market or put into service in Great Britain under Parts 2, 3, or 4 of the Medical Devices Regulations 2002.
Excludes devices intended for clinical investigation or performance evaluation and those with specific authorizations from the Secretary of State.
PMS System (Regulation 44ZE):
Manufacturers must establish and maintain a PMS system for each device.
The system must:
Be proportionate to the device's risk level and appropriate for its type.
Include data collection and analysis throughout the device's lifetime.
Facilitate preventive and corrective actions, including field safety corrective actions (FSCA).
PMS Plan (Regulation 44ZF):
The PMS system must be based on a MHRA PMS plan that:
Details the device's lifetime.
Describes processes for collecting and assessing information, investigating complaints, and managing incidents.
Includes processes for communicating with regulatory authorities, users, and suppliers.
Must incorporate a plan for post-market clinical follow-up (PMCF)Â and provide for periodic safety update reports (PSURs).
Preventive and Corrective Actions (Regulation 44ZG):
Manufacturers must take action to address risks or non-conformities identified during post-market surveillance.
Such actions may include recalls or market withdrawals.
Manufacturers must notify the UK Responsible Person (UKRP) and the Secretary of State when applicable.
Incident Reporting (Regulations 44ZH & 44ZI):
Serious incidents must be reported to the Secretary of State promptly:
Within 15 days for most incidents.
Within 2 days for serious public health threats.
Within 10 days for incidents causing death or unexpected serious deterioration.
Final reports must provide conclusions, actions taken, and details of similar incidents.
Field Safety Corrective Actions (Regulation 44ZJ):
Manufacturers must assess and report field safety corrective actions (FSCA) before implementation, except in urgent cases.
Field Safety Notices must describe the risks and provide actions for users to follow.
Post-Market Reports:
Post-Market Surveillance Reports (PMSRs):
Required for Class I and low-risk devices.
Must be updated every three years.
Periodic Safety Update Reports (PSURs):
Required for higher-risk devices (Class IIa, IIb, III).
First PSUR must be produced within 1 year (or 2 years for Class IIa devices).
Updates are required annually or biennially, depending on device classification.
Retention of Documentation (Regulation 44ZQ):
PMS documentation must be retained for:
At least 15 years for implantable devices.
At least 10 years for other devices.
Trend Reporting (Regulation 44ZN):
Manufacturers must report significant increases in incidents or adverse trends that impact device safety or risk analysis.
Secretary of State’s Oversight:
The Secretary of State can request information, monitor trends, and initiate investigations into incidents or risks identified in PMS.
Implications for Manufacturers
These regulations enforce a robust MHRA PMS framework, requiring manufacturers to:
Continuously monitor and improve device performance and safety.
Maintain detailed documentation and respond to regulatory requests swiftly (within 3 working days when required).
Collaborate effectively with UKRPs and approved bodies.
How AF Pharma Can Help
AF Pharma provides expert support for manufacturers navigating MHRA PMS requirements:
PMS Plan Development: We help create compliant PMS plans tailored to your device.
Incident Reporting: Assistance with timely and accurate reporting of incidents and FSCAs.
PSUR and PMSR Preparation: Comprehensive documentation and updates as per regulatory timelines.
Ongoing Compliance Support: Guidance on trend analysis, documentation retention, and regulatory submissions.
For more information, visit AF Pharma Services. Let us streamline your PMS compliance journey!
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