The European Union’s Restriction of Hazardous Substances (RoHS) directive will impose unnecessary regulatory burdens on devicemakers, according to several groups, including Eucomed and the European Diagnostic Manufacturers Association. Under a new proposal, RoHS, which restricts the use of certain hazardous substances in electrical and electronic equipment, would include medical devices.
NMO is the UK Enforcement Authority for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008 (the RoHS Regulations). These Regulations implement EU Directive 2002/95 which bans the placing on the EU market of new electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.
Manufacturers need to understand the requirements of the RoHS Directive to ensure that their products, and their components, comply.