MEDICAL DEVICES - HARMONISED STANDARDS

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A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.

The references of harmonised standards must be published in the Official Journal of the European Union. The purpose of this website is to provide access to the latest lists of references of harmonised standards and other European standards published in the Official Journal of the European Union (OJEU).

Harmonised Standars for healthcare engineering:

Medical Devices> Click Here

In Vitro Diagnostic Medical Devices> Click Here

Active Implanable Mediac Devices> Click Here

Use of harmonised standards

The use of these standards remains voluntary. Manufacturers, other economic operators, or conformity assessment bodies are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements.

Within the context of some directives or regulations, voluntary European standards supporting the implementation of legal requirements are not called "harmonised standards". This legislation is also included in this information service if:

• legislation foresees a need for a Commission standardisation request to European Standards Organisations;
• publication of references in the Official Journal of the European Union is foreseen as a precondition for presumption of conformity or for other legal effect.