General EU approach
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European Commission http://ec.europa.eu/index_en.htm |
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New Approach New Approach to technical harmonisation and the Global Approach to conformity assessment. http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/index_en.htm |
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List of Directives and standards http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
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European co-operation for Accreditation European network of nationally recognised accreditation bodies based in the European geographical area. http://www.european-accreditation.org/ |
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European Free Trade Association Intergovernmental organisation promoting free trade and strengthening economic relations. http://www.efta.int/ |
Medical links
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General EU index – Medical Devices http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm |
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European Association of Notified Bodies for Medical Devices Notified body recommendations. http://www.team-nb.org/ |
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International Medical Device Regulators Forum International harmonization in the regulation of medical devices. http://www.imdrf.org/ |
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MedTech Europe Largest representative voice of the medical technologies industry in Europe http://www.medtecheurope.org/ |
Current Directives
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List of harmonised standards (MDD) http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm |
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List of harmonised standards (IVDD) http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm |
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List of guidance documents Guidelines relating to medical devices Directives. https://ec.europa.eu/growth/sectors/medical-devices/guidance_en |
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List of Notified Bodies (MDD) http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13 |
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List of Notified Bodies (IVDD) http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20 |
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List of contact points within the National/Competent Authorities https://ec.europa.eu/growth/sectors/medical-devices/contacts_en |
Regulations
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New Medical Device Regulations https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations |
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List of guidance documents (issued by MDCG) https://ec.europa.eu/health/md_sector/new_regulations/guidance_en |
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List of Notified Bodies (MDR) https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 |
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List of Notified Bodies (IVDR) https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 |
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EUDAMED https://ec.europa.eu/health/md_eudamed/actors_registration_en |
Standards
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International Standards Organisation http://www.iso.org/ |
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International Electrotechnical Commission International Standards and conformity assessment for government, business and society for all electrical, electronic and related technologies. http://www.iec.ch/ |
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European Committee for Standardization Voluntary technical standards which promote free trade, the safety of workers and consumers, interoperability of networks, environmental protection, exploitation of research and development programmes, and public procurement. http://www.cen.eu/ |
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British Standards Online British, European or International standards. http://www.bsigroup.com/en-GB/standards/ |
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NEN (Dutch Normalisation Institute) Everything you need to know about standards and standardization. http://www.nen.nl/ |
