Useful Links

European Commission

http://ec.europa.eu/index_en.htm

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

List of Directives and standards

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm

                  European co-operation for Accreditation

                  European network of nationally recognised accreditation bodies based in the European geographical area.

                  http://www.european-accreditation.org/

                        EFTA European Free Trade Association

                       Intergovernmental organisation promoting free trade and strengthening economic relations.

                      http://www.efta.int/

Medical links:

General:

                           European Commission        General EU index – Medical Devices

                           http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm

                    Team NB          European Association of Notified Bodies for Medical Devices

                    Notified body recommendations.

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

                       International Medical Device Regulators Forum

                     International harmonization in the regulation of medical devices.

Directives:

                             European Commission List of harmonised standards (MDD)

                             http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

                              European Commission List of harmonised standards (IVDD)

                              http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm

                               European Commission    List of guidance documents

                               Guidelines relating to medical devices Directives.

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

                               European Commission    List of Notified Bodies (MDD)

                               http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

                                  European Commission                 List of Notified Bodies (IVDD)

                                  http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20

                                      European Commission             List of contact points within the National/Competent Authorities

                                      https://ec.europa.eu/growth/sectors/medical-devices/contacts_en

 European Commission  New Medical Device Regulations 

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations

European Commission   List of guidance documents (issued by MDCG)

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

European Commission   List of Notified Bodies (MDR)

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

 European Commission       List of Notified Bodies (IVDR)

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

European Commission      EUDAMED

https://ec.europa.eu/health/md_eudamed/actors_registration_en

                       ISO  International Standards Organisation

                       http://www.iso.org/

                     IEC     International Electrotechnical Commission

                     International Standards and conformity assessment for government, business and society for all electrical, electronic and related technologies.

                     http://www.iec.ch/

                 CEN       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/

                  BSI        British Standards Online

                  British, European or International standards.

                  http://www.bsigroup.com/en-GB/standards/

                  NEN     NEN (Dutch Normalisation Institute)

                  Everything you need to know about standards and standardization.

                  http://www.nen.nl/