Module 16 2022

07/09/2022

Organisation of the Study

 Groups to be kept to 3-4 with spread of experience  Someone to be appointed to be responsible for time management and topic focus  Review and report back in a single session

The Organisation for Professionals in Regulatory Affairs

5

Company Information • Devices-R-US is a UK company with a manufacturing facility in Ireland. It uses a Notified Body based in Germany 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 and Italy. • Elsewhere in Europe, devices are marketed through independent distributors

The Organisation for Professionals in Regulatory Affairs

6

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