Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

Article 117 NB Assessment {device aspects}

• Quotation and contract with NB

Contract

• NB technical assessment

Technical File

• Technical specialist recommendation

Questions / Responses

Certificate Decision

• Independent review

Summary document/ report

• Issued to manufacturer

With thanks to BSi

The Organisation for Professionals in Regulatory Affairs

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The DDC technical file (STED) – device aspects

Same as for any other Medical device • Structure and content as per IMDRF guidelines

• Including

• GSPR checklist • Clinical evaluation report • Human factors data • Manufacturing / control information

The Organisation for Professionals in Regulatory Affairs

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