RoHS deadlines for devices and IVDs: notified bodies can support longer exemptions
This article was originally published in Clinica
Executive Summary
Medical devices will be included within the scope of the European Commission’s recast of the directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). The deadline for medical devices to comply to this directive is 22 July 2014 and for IVDs, it is 22 July 2016 - unless there is a well supported argument leading to an exemption so that they cancontinue to be allowed on the EU market because of the negative impact of substituting the hazardous substances.