Module 16 2024

24/10/2024

Draft Statutory Instrument (SI) 2024 No XXXX. Medical Devices Post-market Surveillance Requirements

The PMS (SI) applies to medical devices placed on market in Great Britain

Introduces similar requirements to EU MDR / IVDR

• England, Wales & Scotland

Applicable for medical devices placed on market by:

• EU Directives (MDD, AIMD, IVDD) • EU Regulations (EU MDR / IVDR) • UK MDR 2002 (as amended)

Implementation date:

• Early 2025? • Into force 6 months after the day on which they are made

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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Draft PMS SI Summary overview

Part 4A Post market surveillance requirement 44ZC Interpretation of Part 4A (definitions) 44ZD Scope of Part 4A 44ZE Post market surveillance system 44ZF Post market surveillance plan 44ZG Preventive and corrective action 44ZH Initial reporting of serious incidents 44ZI

....make medical devices safer for patients by setting out more stringent requirements when reporting...

Investigation and final reporting of serious incidents Field safety corrective actions (FSCA) and field safety notices (FSN) Field safety corrective actions outside of Great Britain

....identify and analyse safety incidents more swiftly and take action to ensure patients are safe.....

44ZJ

44ZK 44ZL

Post-market surveillance (PMS) report 44ZM Periodic safety update report (PSUR) 44ZN Trend reporting 44ZO Reports received by the Secretary of State 44ZP Analysis of information received under Part 4A 44ZQ Retention of post-market surveillance documentation 44ZR Requests for post-market surveillance documentation

Exclusions/Not included in the PMS SI • Devices intended for clinical investigation • Devices intended for performance evaluation. • Devices under an exceptional use authorisation (EUA)

• Custom made devices are exempt from regulation 44ZK (the requirement to report FSCA outside GB), 44ZL (PMSR), 44ZM (PSUR), 44ZN (trend reporting).

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

12

12

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