UK: Guidelines for Post-market Surveillance of Medical Devices Published
On January 15, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a guidance to clarify the provisions of the recent amendment to the Medical Devices Regulations (Statutory Instrument 2024 No.1368), entitled ‘The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024’.
New Amendment and Main Changes
The amendment amends the UK Medical Devices Regulations (MDR) 2002, introducing a new Part 4, which sets out more stringent requirements for post-market surveillance (PMS). These requirements apply to all Medical Devices, including in vitro diagnostic devices (IVDs) and active implantable devices, marketed in Great Britain (England, Wales and Scotland).
The amendment, which will enter into force on June 16, 2025, aims to improve the traceability of incidents and adverse events, strengthen risk management and device safety, and enable MHRA to intervene timely.
Although the requirements are inspired by European regulations (MDR and IVDR), they differ significantly. For example, notification of Field Safety Corrective Actions (FSCAs) to the MHRA is mandatory for foreign devices, even if they are not marketed in the UK. These differences, while limiting full harmonisation with European legislation, are important in addressing post-Brexit challenges.
Highlights of the Guidelines
The guidelines published by MHRA support manufacturers in implementing the new Post-Market Surveillance (PMS) requirements and offer clarification on obligations, definitions and operational procedures.
The main topics are highlighted below.
Section B: Key Principles of Post-Market Surveillance
- Device lifetime: It is defined as the period between the date of manufacture and the end of the operating cycle during which the manufacturer guarantees that the device will function as intended (validated service life).
- Duration of the Post-Market Surveillance Period: It starts when the first device is placed on the market or put into service, until the end of the life cycle of the last device of the same model.
- Classification of accidents: Criteria for identifying serious accidents, significant health impairments, serious threats to public health and other major events.
Some changes introduced by the SI amendment: No. 1368:
- Definition of the post-marketing surveillance period introduced;
- Clarification of reportable side effects
- Inclusion of self-administered treatment as an intervention to prevent serious health impairment.
Section C: PMS system requirements for manufacturers
- Post-Market Surveillance Plan (PMS): compulsory according to regulations.
- Preventive and Corrective Actions (CAPA): obligation to notify the UK Authorised Representative (UKRP) and, if applicable, the UK Notified Body, for any action taken to manage risks or nonconformities affecting the performance or safety of the device.
- Post-marketing surveillance reports PMSR and PSUR: mandatory inclusion in regulatory documents.
One main change was introduced. The UKAB will evaluate corrective and preventive actions to assess their impact on device certification.
Section D: reporting within the supervisory system
- Persons obliged to report: clarification of who must report.
- Types of reportable events: expansion of categories.
- Timing: reduction of the time to report an expected serious deterioration in health condition from 30 to 15 days.
- Mode of presentation: improvements in the structure and elements required in reports.
For more details and further information, see the full guidance.
Implications for the Manufacturer
Manufacturers must prepare themselves in good time by delving into the details of the amendment and guidelines, so as to be compliant by the deadline of June 16, 2025. MHRA encourages companies to provide feedback via trade associations to further improve the guidelines before they come into force.
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01/22/2025
