New EU Regulations for medical devices are underway

After an agreement in June 2016 between the European Council and the European Parliament two new EU Regulations for medical devices and in vitro diagnostic medical devices are underway, replacing existing Directives. The Regulation on medical devices, which will probably be adopted next year, will contain a 0.1% concentration limit for category 1A and 1B CMR substances and for endocrine disrupting chemicals. Medical devices with such substances above this concentration intended to come into direct contact with patients have to be labelled accordingly and, if they are used for treatment of children or pregnant or nursing women, a specific justification, based on a scientific assessment and an analysis of alternatives, is required.

More information on the EU rules for medical devices can you get here or by contacting Klaus Schneider.