Module 19 2021

24/05/2021

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

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

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Other guidance on technical documentation

• ‘Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices’ March 17th, 2011 • ‘In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)’ 21 March 2019 http://www.imdrf.org/search.asp?zoom_query=documentation http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-ivd-mdma-toc-n13.pdf

The Organisation for Professionals in Regulatory Affairs

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