Module 16 2024

TOPRA Module 16

– Post Market Surveillance and Vigilance for Medical Devices

TOPRA Office, 6 th Floor, 3 Harbour Exchange, London,

Thursday 24 th October 2024

Case Study: Assessing complaints

Dr David Mandley, Principal Regulatory Consultant, NAMSA

Practicalities

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

• Appoint someone to take notes and be a spokesperson for your group.

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

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

Company background - Devices-For-You

• Devices-For-You is a UK company with a manufacturing facility in Ireland.

• It uses a Notified Body based in The Netherlands for EU, and a UK Approved Body for Great

Britain.

• Using its office in Ireland the UK company CE marks devices manufactured in Europe and

currently acts as AR for devices distributed in Europe but manufactured outside Europe.

• The UK Company markets products in Great Britain (with UKCA marks and CE marks) and

Ireland.

• Devices are marketed through wholly owned subsidiaries in France, Germany, Italy and

Spain.

• Elsewhere in Europe, devices are marketed through independent distributors.

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