Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR technical documentation, some key points

• Impact on legacy devices • 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

The Organisation for Professionals in Regulatory Affairs

51

52

Brexit and technical documentation

The Organisation for Professionals in Regulatory Affairs

52