Medical device CE marking


General EU approach

European Commission European Commission
European Commission New Approach
New Approach to technical harmonisation and the Global Approach to conformity assessment.
European Commission List of Directives and standards
European Accreditation European co-operation for Accreditation
European network of nationally recognised accreditation bodies based in the European geographical area.
EFTA European Free Trade Association
Intergovernmental organisation promoting free trade and strengthening economic relations.

Medical links


European Commission General EU index – Medical Devices
Team NB European Association of Notified Bodies for Medical Devices
Notified body recommendations.
International Medical Device Regulators Forum
International harmonization in the regulation of medical devices.
MedTech Europe
Largest representative voice of the medical technologies industry in Europe

Current Directives



ISO International Standards Organisation
IEC International Electrotechnical Commission
International Standards and conformity assessment for government, business and society for all electrical, electronic and related technologies.
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.
BSI British Standards Online
British, European or International standards.
NEN NEN (Dutch Normalisation Institute)
Everything you need to know about standards and standardization.