Understanding the Scope of UK PMS Requirements
Out of Scope
These requirements do not apply to devices subject to clinical investigation, performance evaluation or exceptional use authorisation in GB. They also do not apply to medical devices manufactured in house by healthcare establishments (regardless whether custom-made)
These requirements do not apply if a manufacturer no longer places any further individual devices of a device model on the GB market or puts them into service after 16 June 2025, the date on which this SI comes into force (that is, they are discontinued prior to commencement)
Reporting in the Post Market Surveillance System
| Device Category | PMS Requirements | Exemptions |
|---|---|---|
| Custom-made devices | Must comply with most UK PMS rules | Exempt from: a. Field Safety Corrective Actions (FSCAs) outside GB (Reg 44ZK) b. PMS Report (PMSR)(Reg 44ZL) c. Periodic Safety Update Report (PSUR)(Reg 44ZM) d. Trend Reporting (Reg 44ZN) |
| Procedure pack manufacturers | Must follow all PMS obligations | Exempt from: a. PMS Report (PMSR)(Reg 44ZL) b. Periodic Safety Update Report (PSUR)(Reg 44ZM) |
Implications for Manufacturers
Once this legislation becomes law, manufacturers must prepare to take on stricter PMS obligations than those currently in place from 16 June 2025 for medical devices on the market in GB. This will involve amending any current PMS systems, developing PMS plans, and having procedures in place to promptly report and act on incidents, corrective actions and trends in accordance with the GB requirements.
Any PMS policies procedures already developed to handle the EU MDR or IVDR will need to be reviewed in light of the GB law. Amendments are likely to be necessary to meet the differing GB requirements to ensure future compliance for devices placed on the market or put into service in GB.
MHRA Expectation (Non-Binding but Important):
Refrences
Legislation
MDR - Article 88 - Trend reporting - Medical Device Regulation
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