About 10 new harmonised standards provide presumption of conformity for medical devices Publicado em: 03/09/2012
On 30 August 2012 new consolidated lists of references of harmonised standards under the three (main) medical devices directives were published in the Official Journal of the European Union.
The harmonised European standards, the references of which have been published in the Official Journal C 262, provide solutions for compliance and confer a presumption of conformity with the essential health and safety requirements of the medical devices directives that they cover.
However, the use of harmonised standards remains voluntary and manufacturers can choose whether or not to follow a harmonised standard to manufacture their products. Manufacturers may thus use other technical solutions providing for an equivalent level of safety. In that case, they must be able to prove that their products are in conformity with the mandatory essential health and safety requirements, taking due account of the state of the art.
For informative purposes the new and changed standards compared with the previous consolidated lists are marked with the term '(new)' in the summary tables in Web format on the relevant pages:
- Directive 90/385/EEC for active implantable medical devices
- Directive 93/42/EEC for medical devices
- Directive 98/79/EC for in vitro diagnostic medical devices.
For more information on the medical devices directives:
Directorate General for Health and Consumers