On October 22nd, 2013, the European Parliament voted in favour of the European Commission’s proposed ban on the use of hazardous chemicals in medical devices.
The ban applies to chemicals that are CMR (carcinogenic, mutagenic and toxic to reproduction) and EDCs (endocrine disrupting chemicals) that are contained in medical devices and come into contact with the body of patients or are used to administer, transport or store medicines, body fluids or other substances, including gases in concentrations above 0.1% by weight.
The use of CMR and EDC in devices used to treat children or pregnant/nursing women should be phased out within 8 years of the regulation going into force. That is unless the manufacturer can prove there is no suitable or safer alternative to a device containing these substances.
As well as this new proposal, there are many other laws relating to hazardous substances for medical devices, please see an overview in the table below.