Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex II, main headings

3.2. Manufacturing information

Incoming inspection of critical raw materials/active ingredients Specifications and final concentrations/quantities of critical raw materials/active ingredients (subcomponents for instruments) in the finished device In-process QC Final release QC, with the CoA.’

Provide detailed information on:

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, 3.2. Manufacturing information

In case of sub-contracted (outsourced) processes:

‘For critical component suppliers (e.g., outsourced manufacturing of sterile device) overview of manufacturing processes and corresponding control measures (e.g., references to verification and validation activities, copy of the certificate shall be included).’

‘For non-critical component suppliers (e.g., bulk) identification of supplier only.’

The Organisation for Professionals in Regulatory Affairs

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