New Post-Market Surveillance Rules for UK Medical Devices

The publication of Statutory Instruments 2024 No. 1368 introduces significant amendments to the Medical Device Regulations in Great Britain. These changes, aimed at enhancing the safety and performance monitoring of medical devices, are designed to ensure higher standards of public health protection.

Key Highlights of the Amendments

• • Comprehensive Post-Market Surveillance (PMS) Requirements
    • A new Part 4A has been added to the Medical Devices Regulations 2002, detailing PMS requirements for medical devices and accessories.
  • Updated Definitions
    • Definitions for key terms such as “corrective action,” “field safety corrective action,” “incident,” “serious incident,” and “post-market surveillance” have been updated to ensure clarity and consistency.
  • Enhanced PMS System Requirements
    • Manufacturers must now maintain a PMS system proportionate to the device’s risk and type. This system must include:
      • Data analysis.
      • Identification of actions.
      • Data utilization to update various technical documents.
  • Structured PMS Plan
    • The PMS plan must be clear, organized, and maintained throughout the device’s PMS period. It should include processes for:
      • Collecting and assessing information on incidents, side effects, user feedback, and trends.
  • PMS Report / PSUR Requirements
    • Lower Class Devices: Require a Post-Market Surveillance Report (PMSR).
      • First PMSR must be produced within 3 years of market entry and updated every 3 years.
    • Higher Class Devices: Require a Periodic Safety Update Report (PSUR).
      • PSURs must be updated every 2 years for medium-risk devices and annually for high-risk devices.
    • PMSR requirements do not apply to systems or procedure packs unless:
      • They incorporate a non-UKCA or non-CE marked medical device.
      • The combination of devices is incompatible with their intended use.
  • Incident Reporting and Management
    • Manufacturers must report serious incidents to the Secretary of State following updated timelines:
      • Immediately after establishing a causal relationship.
      • 15 days for general incidents.
      • 2 days for public health threats.
      • 10 days for deaths or serious health deteriorations.
  • Field Safety Corrective Actions (FSCAs)
    • Before implementing any FSCA, manufacturers must:
      • Produce a risk assessment.
      • Submit an initial report and proposed field safety notice to the Secretary of State.
    • Urgent FSCAs can be reported after implementation if necessary.
  • Documentation Retention
    • PMS documentation must be retained for:
      • 10 years after the device is placed on the market.
      • 15 years for implantable devices.

Implementation Date

The amendments will come into effect on 16 June 2025.

These changes are a significant step forward in improving the safety and performance monitoring of medical devices. Regulatory Affairs professionals are encouraged to update their processes and systems to comply with these new requirements.

For full details, refer to The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

If you have feedback or if you need assistance understanding how these updates may impact your medical device applications, contact us for expert support.

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