The MHRA have released their guidance on new GB PMS requirements, introduced with the new PMS Statutory Instrument. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Device Regulations 2002.
The MHRA recommends members to start using the guidance immediately, to ensure you are prepared for when the new PMS requirements become mandatory from 16th June 2025, and are seeking feedback based on your experience.
Please submit any feedback to regulatory@bivda.org.uk.
The updated requirements and guidance do not apply to products placed on the Northern Ireland market as the EU IVD Regulation 2017/746 applies to products placed on the NI market, including PMS requirements.
The updated guidance can be found here. The full press release can be found here.
