Status as of October 2013
MDSS has evaluated the RoHS directive and has thought of questions a manufacturer may ask. We also address the answer with the reference to the legal wording of the directive. Nevertheless we have to state that MDSS is not a law firm and provides this information to the best of its knowledge with its professional background as being in the regulated area for many years. However, should you come to any conclusion based on the answers given, please consult the directive or we advise to seek legal counseling.
The RoHS directive applies to (RoHS RL 2011/65/EU Article 4 Paragraph 3):
- All medical devices placed on the market from July 22, 2014 and falling under the definition of Electrical and Electronic Equipment
- All IVD products placed on the market from July 22, 2016 and falling under the definition of Electrical and Electronic Equipment
As of today, active implantable medical devices are still excluded from this directive. In case of larger electrical medical devices such as an MRI scanner, it has to be clarified upfront whether this device falls under the term “large-scale fixed installation”, as then the RoHS directive would no longer be applicable.
The compliance with the RoHS Directive can be demonstrated with a technical documentation and EU declaration of conformity according to Annex VI (Directive 2011/65/EU). The technical documentation and the EU declaration of conformity must be kept available for 10 years after the product has been placed on the market.
For further information please contact us.
LINK: RoHS 2011/65/EU
Please click here to access the questions