Module 16 2024

21/10/2024

Logistics

• Work in groups of 2-3 max … with a spread of experience

• Appoint someone to take notes and be a spokesperson

• Aim to work through a minimum of five (5) scenarios

• Review and be prepared to report back in a group session

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Useful references and documentation

• MEDDEV 2.12-1 rev 8*

• EC Docs Room

• MDCG endorsed documents

• MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (Feb 2023) • MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) (Jul 2022)

• MedTech Europe

➢ Revised Manufacturer Incident Reporting form and new Vigilance-related guidance documents published * NOTE: Some incident reporting forms have been updated – refer to MedTech Europe and EC Docs Room

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