Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Other guidance on technical documentation

MDCG 2019-13 ‘Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation’ Publication date: December 2019 ‘The depth and extent of the technical documentation assessment of Class IIa / IIb and Class B / Class C devices will be the same as the depth of assessment carried out for Class III and Class IIb implantable and Class D devices.’

The Organisation for Professionals in Regulatory Affairs

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