July 28, 2023
By Karen Hill
On July 26, 2023, the World Trade Organization (WTO) published notification of the draft Post-Market Surveillance Requirements Statutory Instrument (PMS SI), which includes a link to the draft PMS SI, providing interested stakeholders with early notice of the intended legislative changes related to Post-Market Surveillance (PMS) for medical devices in Great Britain. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is a member of WTO and intends to implement the PMS SI.
As previously reported by Emergo by UL, the MHRA had announced in January 2023 that there would be an SI on PMS released in the summer with implementation in the winter 2023/early 2024.
Under the current UK legislation (UK MDR 2002, as amended) once a medical device has been placed on the market, the manufacturer is obliged to continually monitor its performance; however as the original UK MDR 2002 was based on the European Medical Devices Directive (MDD 93/42/EEC) and other European directives, there are limited regulatory provisions regarding PMS provided in the legislation and instead details on how to conduct PMS and vigilance are covered in non-binding guidance, leading to inconsistencies in performance and reporting.
The objective of the new legislation is to introduce clearer PMS requirements that are risk proportionate, with improved regulatory oversight. Many of the proposed PMS provisions are aligned with the European Medical Devices Regulation (MDR 2017/745).
Key changes include:
- Increased scope of devices that must comply with the new PMS requirements, including CE marked devices.
- Details of what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonization across manufacturers.
- Reporting timescale for serious incidents reduced from 30 days to 15 days to support the detection of safety issues sooner.
- Set timeframes for reporting of PMS data (dependent on device classification) to support earlier detection of trends/signals that may have an impact on the safety of a medical device.
WTO members have 60 days to comment to the Department of International Trade.
The proposed date of adoption is December 2023, with a proposed date of entry into force of June 2024. Based on this timeline, the PMS SI will be published later than originally expected.
As many of the provisions are related to the MDR, it is not expected that there will be significant feedback to the drafted legislation.
We anticipate that the MHRA will publish accompanying guidance.
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