General EU approach: |
| 
| - 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/enterprise/newapproach/index_en.htm |
|
| - List of directives and standards
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html |
 | - European co-operation for Accreditation
European network of nationally recognised accreditation bodies based in the European geographical area.
http://www.european-accreditation.org/ |
 | - European Free Trade Association
Intergovernmental organisation promoting free trade and strengthening economic relations.
http://www.efta.int/ |
Medical links: |
|
| - General EU index - Medical Devices
http://ec.europa.eu/consumers/sectors/medical-devices/regulatory-framework/index_en.htm |
|
| - Revision of the Medical Device Directives
http://ec.europa.eu/consumers/sectors/medical-devices/documents/revision/index_en.htm |
|
| - List of MEDDEV documents
Guidelines relating to medical devices Directives.
http://ec.europa.eu/enterprise/sectors/medical-devices/documents/guidelines/index_en.htm |
| - List of harmonised standards (MDD)
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm |
| - List of harmonised standards (IVDD)
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/iv-diagnostic-medical-devices/index_en.htm |
|
| - List of Notified Bodies
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main#
|
|
| - List of contact points within the National/Competent Authorities
http://ec.europa.eu/enterprise/sectors/medical-devices/files/list-of-contact-points-within-the-national_en.pdf |
| - List of contact points within the National/Competent Authorities (Vigilance reporting)
http://ec.europa.eu/enterprise/sectors/medical-devices/files/list-of-vigilance-contact-points-within-the-national_en.pdf |
 | - European Association of Notified Bodies for Medical Devices
Notified body recommendations.
http://www.team-nb.org/ |
 | - Global Harmonisation Task Force
International harmonization in the regulation of medical devices.
http://www.ghtf.org/ |
 | - Eucomed
Largest representative voice of the medical technologies industry in Europe
http://www.eucomed.be/ |
Standards: |
 | - International Standards Organisation
http://www.iso.org/ |
 | - International Electrotechnical Commission
International Standards and conformity assessment for government, business and society for all electrical, electronic and related technologies.
http://www.iec.ch/ |
 | - 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.cenorm.be/ |
 | - British Standards Online
British, European or International standards.
http://www.bsonline.bsi-global.com/ |
 | - NEN (Dutch Normalisation Institute)
Everything you need to know about standards and standardization.
http://www.nen.nl/ |
Other: |
 | - Consultants Europe
Technical and Legal organisation specialized in the CE mark, CE marking, CE certification and Authorized Representation of products.
http://www.cemark-global.com/ |
 | - CE-solutions
for professional answers for all questions regarding the application of CE-marking and the European directives.
http://www.cesolutions.nl / |
| | |
| | |
