cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
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RoHS II EU Directive

Restriction of use of hazardous substances (RoHS)

In June 2011, the recast of the RoHS Directive (202/95/EC) has been 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. The European Directive is requested to be transposed at country level by 2 January 2013.

According to RoHS II, medical devices containing the six substances will no longer be allowed on the European market from 22 July 2014 (three years after the publication in the Official Journal) and from 22 July 2016 for in-vitro diagnostic devices (IVD).

COCIR developed a lot of efforts towards the European Commission, European Parliament and European Council during their discussions on the recast and submitted 2 documents (in 2009 and 2010) providing the status on what were the additional requested exemptions that should have been included in annex IV to ensure a sustainable market for healthcare industry as today some of the applications have no alternatives.

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:

  • The new Directive does not sufficiently address the case of refurbished medical devices that follow the environmentally-sound concept of reuse.
  • Only a few of the exemptions requested by COCIR have been integrated into Annex IV thus requiring COCIR companies to submit each additional exemption through a lengthy administrative process through the European Commission.

 

Requested additional exemptions

Despite several requests to the Commission, the European Parliament and European Council, the COCIR proposed additional exemptions were not included in the adopted RoHS Directive.

COCIR submitted additional 12 exemptions required by its members between September 2011 and May 2012. All requested exemptions have been published on the Opens external link in new windowOfficial Journal of the European Union on 9 January 2014:

The COCIR consolidated version of Annex IV as of 9 January 2014 is available Initiates file downloadhere