About 10 new harmonised standards provide presumption of conformity for medical devices

Type: European standards and norms
Source of information: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
Sector: Biomedical and Health
iCON Sector:
Issuing organization: European Commission
Publication date: 03/09/2012
Date of entry into force:
Attachments : No file!
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.
posted on 19/09/2012