Wednesday, May 18, 2011

New RoHS EU Directive Is Coming To A Medical Device Company Near You…

The RoHS directive is intended to restrict the use of certain hazardous substances in electrical and electronic equipment (EEE).  The EU Commission now plans to recast RoHS as part of its overall commitment for a better regulatory environment.   The work on the revision started in 2008 and the revision is ready to be presented as “RoHS Recast” because the current directive will be repealed or replaced. One of the major modifications to the directive will be inclusion of medical devices and monitoring and control instruments in its scope and to the adaptation of the list of restricted substances.
In the current EU RoHS directive, medical device (MDD) and IVDs are exempt from RoHS compliance requirements. However, in the new proposed RoHS directive, MDD and IVDD devices will be removed from the automatic RoHS compliance exclusion list, except active implants under AIMDD. This change will have significant impact on medical device companies.  The Commission expects higher costs for complex products that are produced in low numbers and have critical applications. However, the proposed changes will be staged to allow the conversion to take place. The medical device companies must comply within three years after the publication of the directive, whereas IVDs must comply within five years.
So MDD and IVD companies have two choices available to them after the publication of this directive
(1)    Apply for specific exemptions, which is granted for 7 years
(2)    If exemption is not approved or filed, companies must comply with the directive by setting up a self-declaration of conformity referring to the RoHS. This will require manufacturers to maintain technical documentation, cite relevant standards, implement internal production controls and keep a register of the nonconforming products.  In addition, EC declaration of conformity that accompanies the finished product should be in the local language.
It is also required that manufacturers  add CE mark on the finished product, as well as their name, trademark, contact address, and a type, batch or serial number on the product labeling.

The EU Commission website for recast of RoHS Directive

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