Support - EU Medical Devices Directives

Useful Links

 European Directives
Guidelines & Information - Medical Devices
Regulatory Authorities & Other Useful Sites
AMTAC Marks and Logos

 
 Medical Devices and CE marking
Introduction
EU Medical Devices Directive
        Guide to Implementation
        Downloads - EU Directives Medical
        Downloads & Links
                 AMTAC Support
ISO 13485/ EN 46001 - QMS for Medical Devices
In Vitro Diagnostics Directive
   

 

    

European Directives

ITEM DESCRIPTION FORM PASSWORD
1 Medical Devices Directive 93/42/EEC PDF: 195k No
2 In-Vitro Diagnostic Medical Devices Directive 98/79/EC PDF: 348k No

Guidelines & Information - Medical Devices Directives
ITEM DESCRIPTION FORM PASSWORD
1 HIGHLY RECOMMENDED
EC Website for Medical Devices 		Weblink No
2 Guidance Bulletins & Notes from the UK Medicines and Healthcare products Regulatory Agency Weblink No
3 List and Text of of 'New Approach' Directives Weblink No
4 List of Harmonised Standards re: 93/42/EEC Weblink No

Regulatory Authorities & Other Usefull websites

EU Directives & Harmonised Standards
European Organisation for Comformity Assessment - Comprehensive listing of standards and directives
EU Guidelines relating to medical devices Directives (Medevs)
European Documentation (Medevs and NB-Med) Via Donowa and Associates
EUROPA - The European Commission Online
EUCOMED
FDA - Food & Drug Administration, USA
HIMA - Health Industry Manufacturers Association
GHTF - Global Harmonisation Task Force
ISO - International Organisation for Standardisation
MHRA (formerly the MDA) - Medicines and Healthcare products Regulatory Agency (the UK Competent Authority)
NEMA - National Electrical Manufacturers Association
RAPS - Regulatory Affairs Professionals Society
TGA - Therapeutic Goods Administration (Australia)
EDMA - European Diagnostic Manufacturers Association

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