Standards

EC Harmonized Standards

Harmonized standards are European standards, which are developed under a mandate from the EC (European Commission) and/or EFTA (European Free Trade Association) and which supports the 'essential requirenments' of a New Approach Directive of the European Union (e.g. AIMD, MDD, IVDD). If in addition, its reference is published in the OJEC (Official Journal of the European Communities), it gives presumption of conformity to the related Directives.

A comprehensive listing of the Harmonized standards available to date (source NB-MED) can be downloaded in portable document format (pdf) as follows:

Alternatively one may refer to the following sites:

• European Commission: Medical Devices: Active Implantable Medical Devices (AIMD) - harmonizsed standards

• European Commission: Medical Devices: General Medical Devices (MDD) - harmonized standards

• European Commission: Medical Devices: In Vitro Diagnostic Medical Devices (IVDD) - harmonized standards

Other European Standards

Standard activities, in the different medical device categories under the respective directives, currently undergoing consideration by CEN or CENELEC can be referenced from the following official links:

• New Approach: standard activities - In Vitro Diagnostic Directive (IVDD)

Other Standards

Please refer to the standards institutions on the following page:
Institutions/Associations Worldwide

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Last updated: 2010-04-22

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