Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Appendix: Useful links

European Commission: ● https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

● http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 ● https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other guidance_en MHRA: ● https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices and-extension-of-standstill-period ● https://www.gov.uk/government/publications/in-vitro-diagnostic-medical-devices-guidance-on-legislation Other: ● http://www.imdrf.org/documents/documents.asp ● https://www.bfarm.de/EN/Medical-devices/_node.html ● https://www.team-nb.org/team-nb-documents/ ● bit.ly/3sHnXip

The Organisation for Professionals in Regulatory Affairs

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Appendix: Other guidance on technical documentation

Recommendation NB-MED/2.5.1/Rec5 ‘Technical Documentation’ Publication date: 03.02.2000

http://www.team-nb.org/nb-med-documents/

This Recommendation was not written for IVD’s but could still be of use to IVD manufacturers.

The Organisation for Professionals in Regulatory Affairs

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