The recast of the Restriction of Hazardous Substances (RoHS) Directive

The recast Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (2011/65/EU) will apply to medical devices placed on the market from 22 July 2014 and to in vitro diagnostic medical devices placed on the market from 22 July 2016; although there are various general (e.g. Annex III) and specific (Annex IV) exemptions.  There are important consequences for manufacturers of medical devices relating to the declaration of conformity with Directive and CE-marking.  However, there is provision for demonstrating compliance with the requirements of the Directive within the context of other applicable EU legislation requiring conformity assessment procedures that are at least as stringent.   A single technical documentation may be drawn up.  Records (e.g. technical documentation, declaration of conformity) must be kept for ten years after the device is placed on the market.

Wainwright Associates’ consultants can provide advice on the implications of these changes, please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554 to see how we can help.