The EU’s new directive regarding the Restriction of use of certain Hazardous Substances (RoHS) in electrical and electronic equipment (EEE) came into effect for medical devices as of July 22 2014.
RoHS 2, or Directive 2011/65/EU, was intended to improve regulatory conditions through a “simple, effective, and enforceable Directive” that aims to harmonize EEE regulations with other changes to the rest of EU legislation. Since it entered into force in 2011, Member States were required to incorporate it into national law by 2013. July 22nd of this year is the date when the law comes into effect for most medical devices, though some devices are exempt (see Annex IV). In vitro diagnostic devices must be compliant by 2016 and all eligible EEE products must be compliant by 2019.
RoHS 2 stipulates that manufacturers must prepare the required technical documentation, carry out an internal production control procedure, draw up an EC Declaration of Conformity, and affix the CE Mark to their product. However, despite the stated goals of the new directive, RoHS 2 outlines the responsibilities of the manufacturer but does not contain a mandate for Notified Body assessment of compliance with the provisions.
Currently, Notified Bodies are assessing RoHS 2 compliance as part of the ongoing assessment of technical files for new applications and sampling of technical files for existing CE marked devices. Manufacturers are legally obligated to have completed the minimum requirements (items one and two below) and provide evidence when asked.
There are four steps recommended by Arazy Group in order to reach compliance:
1. UPDATE THE CURRENT TECHNICAL FILE: According to EN 50581 (technical documentation for the assessment of EEE), manufacturers should provide evidence of their compliance with RoHS 2 either through a single document or by other means. This must be provided during the annual review of the technical file or during the assessment of new files.
2. DRAW UP A DECLARATION OF CONFOMITY: The Declaration of Conformity must meet the requirements of RoHS Directive, Annex VI and be signed and dated by an identifiable individual.
3. RoHS AWARENESS TRAINING AND PRESENTATIONS: Ensure that your team is aware of and prepared to deal with the changes that may affect your company.
4. REVIEW GAP ANALYSIS REPORT: The Gap Analysis report of the device’s technical file must be verified as compliant with EN 50581 requirements.
Arazy Group can help you be prepared for RoHS 2 compliance and assessment! Our team of experts can assist you with compiling the required documentation, technical documentation assessment (according to EN 50581), drawing up the declaration of conformity (template provided), RoHS 2 compliance training, RoHS 2 SOP, and/or an optional internal audit.
If you have further questions, please contact us at firstname.lastname@example.org or refer to the FAQ provided by the EU for more information about the requirements.