Module 19 2021

24/05/2021

Learning Outcomes

Technical documenation • What is it? • How should it be compiled? • What is STED? • How to write a DoC

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IVDR, some key points

• Impact on legacy devices • Intervention of NB for most IVD’s • Notified body expertise and readiness • Engagement of manufacturers with NB’s • Conformity with GSPR’s not ER’s • Consistency between technical files • Maintenance of new technical files • New DoC’s to be issued • Impact of CS, implementing acts, guidance

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