Module 19 2021

24/05/2021

Useful links

European Commission: ● http://ec.europa.eu/growth/sectors/medical-devices/regulatory- framework/revision_en ● http://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 ● http://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 ● https://ec.europa.eu/health/md_sector/new_regulations/guidance_en MHRA: ● 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/MedicalDevices/LegalFramework/tasks/_node.html ● http://www.team-nb.org//wp- content/uploads/2015/05/nbmeddocuments/Recommendation-NB-MED- R2_5_1-5_rev4_Technical_Documentation.pdf

The Organisation for Professionals in Regulatory Affairs

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