The EU RoHS Directive (2011/65/EU) substance restrictions and other compliance requirements come into effect today for most medical devices (category 8) and monitoring and control instruments (category 9).
Key obligations for manufacturers to implement/document Compliance Assurance System are:
- draw up the required technical documentation and carry out the internal production control procedure;
- ensure that their products have been designed and manufactured in accordance with the requirements for substance restrictions;
- ensure that procedures are in place for series production to remain in conformity;
- take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and with the requirements of the RoHS Directive;
- EU declaration of conformity
- register of non-conforming EEE and product recalls, and keep distributors informed;
- ensure that their EEE bears a type, batch or serial number or other element allowing its identification;
- materials, components and EEE which have been tested or measured in accordance with harmonised standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive
The RoHS Directive obligates manufacturers to draw up ‘Technical Documentation’ that demonstrates conformity prior to placing products on the EU market. The CENELEC EN 50581 standard specifies requirements for RoHS 2 technical documentation.
Contact ECD Compliance for additional information and support on RoHS compliance or for an independent assessment or guidance on your current RoHS conformity assessment procedures.