In June 2011, the recast of the RoHS Directive (202/95/EC) was published on the Official Journal as Directive 2011/65/EU, banning six substances (lead, cadmium, chromium VI, mercury, PBB and PBDE) from electrical and electronic equipment. 4 additional substances (phthalates) were added in 2015 by the EC Delegated DIrective 2015/863:
According to RoHS II, medical imaging devices containing the six substances were no longer be allowed on the European market from 22 July 2014. The restriction on phthalates will enter into force in July 2021.
While supporting the objectives of the Directive, COCIR is concerned about two main aspects as those will generate market uncertainty and will affect ability of industry to develop new products:
COCIR submitted additional 12 exemptions required by its members between September 2011 and May 2012. All requested exemptions have been published on the Official Journal of the European Union on 9 January 2014.
In January 2020 COCIR submitted 20+ exemption renewal requests, both in Annex III and IV.