๐ง๐ต๐ฒ ๐ป๐ฒ๐ ๐ฝ๐ผ๐๐-๐บ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐๐๐ฟ๐๐ฒ๐ถ๐น๐น๐ฎ๐ป๐ฐ๐ฒ ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ ๐๐ฒ๐ ๐ฏ๐ ๐๐ต๐ฒ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ถ๐ป๐ฒ๐ ๐ฎ๐ป๐ฑ ๐๐ฒ๐ฎ๐น๐๐ต๐ฐ๐ฎ๐ฟ๐ฒ ๐ฝ๐ฟ๐ผ๐ฑ๐๐ฐ๐๐ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ด๐ฒ๐ป๐ฐ๐ ๐ฎ๐ฟ๐ฒ ๐ด๐ผ๐ถ๐ป๐ด ๐ถ๐ป๐๐ผ ๐ฒ๐ณ๐ณ๐ฒ๐ฐ๐ ๐ผ๐ป ๐๐๐ป๐ฒ ๐ญ๐ฒ, ๐ฎ๐ฌ๐ฎ๐ฑ.
๐ง๐ต๐ฒ ๐ฒ๐๐ต ๐ผ๐ณ ๐ข๐ฐ๐๐ผ๐ฏ๐ฒ๐ฟ, ๐ฎ๐ฌ๐ฎ๐ฑ ๐๐ถ๐น๐น ๐ฏ๐ฒ ๐๐ต๐ฒ ๐น๐ฎ๐๐ ๐ฑ๐ฎ๐ ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ฒ๐ฟ๐ ๐บ๐ฎ๐ ๐ฟ๐ฒ๐ฝ๐ผ๐ฟ๐ ๐๐๐ถ๐ป๐ด ๐๐ต๐ฒ ๐ฒ๐ ๐ถ๐๐๐ถ๐ป๐ด ๐ณ๐ฟ๐ฎ๐บ๐ฒ๐๐ผ๐ฟ๐ธ (๐ฏ๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ป๐ด ๐ฎ๐ฑ๐ฑ๐ถ๐๐ถ๐ผ๐ป๐ฎ๐น ๐ถ๐ป๐ณ๐ผ ๐๐ผ ๐บ๐ฒ๐ฒ๐ ๐๐ต๐ฒ ๐ป๐ฒ๐ ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐).
Starting June 16, the new requirements will apply to:
๐All medical devices and IVDs with UKCA marking
๐CE-marked products under MDR/IVDR, which may continue to be sold in Great Britain until June 30, 2030
๐กDevices marketed exclusively in Northern Ireland or devices withdrawn from the British market before June 16, 2025, are not affected.
Exemptions apply only to:
โ๏ธ Investigational Devices used in clinical investigations
โ๏ธIVDs under performance evaluation
โ๏ธDevices approved for exceptional use (e.g., humanitarian or military)
โ๏ธCustom-made devices (partially exempt)
๐ก Northern Ireland will continue to follow the European framework, but the MHRA will oversee device registration.
Major requirements
โ๏ธMandatory PMS system and PMS plan that can ensure continuous evaluation of product performance and potential risks throughout the product lifecycle.
โ๏ธNew reporting obligations and the standardized #PSUR format
โ๏ธExpanded data collection and harmonised serious-incident reporting timelines
โ๏ธManufacturers must implement trend reporting to identify significant changes in the frequency or severity of incidents and notify the MHRA accordingly.
โ๏ธEnhanced granularity on Field Safety Corrective Actions #FSCA and communication protocols
The British Authority has published a short presentation on the changing regulations providing further clarifications following stakeholder feedback
Remember
You can also benefit from Evnia’s expertise and UK representation services!
Contact us to learn how we can help you align your PMS system with the new British requirements and how we can support you throughout the implementation process!
