Module 16 2024

24/10/2024

Draft PMS SI PMS Plan, PMS Report, PSUR

Similar requirements to those in EU MDR Article 84 (PMS Plan), 85 (PMSR) & 86 (PSUR)

• Information collected based on the PMS Plan must enable: • An accurate characterisation of device performance • Comparison with other similar products on market

• must be clear, organised and searchable • processes to gather information (ensuring comprehensive real-world data obtained) • methods of data analysis • processes for fulfilment of Vigilance Reporting obligations • links to preventive and corrective action as part of a risk management process

PMS Plan

• Include summary of results and conclusions of information collected based on PMS plan • Description of preventive or corrective actions • Produced within 3 years of device being placed on market • Updated every 3 years

• post-market surveillance report (PMSR) required for: • Class I medical devices under UK MDR 2002, EU MDD, EU MDR • Class A or B IVDs under EU IVDR

• IVDs placed on the market or put into service in accordance with Part 4 of UK MDR 2002 and that is not a device referred to in the lists in Annex II of Directive 98/79

PMSR

• Include summary of results and conclusions of information collected based on PMS plan • Description of preventive or corrective actions • UK specific data • Risk based production and updated periods

• Periodic Safety Update Report (PSUR) required for all medical devices placed on GB market (except class I) • Standardised format expected

PSUR

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

2024-10-24

13

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Draft PMS SI / EU MDR Article 87 Viglance & FSCA Reporting Timelines

• Notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event

• Report (via EUDAMED) immediately after established the causal relationship between incident and their device

Reporting

Serious public health threat Death or unanticipated serious deterioration in state of health Anticipated serious deterioration in state of health

• No later than 2 calendar days after the manufacturer becomes aware

• No later than 2 calendar days after the manufacturer becomes aware

• No later than 10 calendar days after the manufacturer becomes aware

• No later than 10 calendar days after the manufacturer becomes aware

• No later than 15 calendar days after the manufacturer became aware

• No later than 15 calendar days after the manufacturer became aware

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

2024-10-24

14

14

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