The technical documentation for compliance to RoHS 2 is the greatest challenge for manufacturers of products that were already RoHS compliant. We can provide a template for technical documentation and assist you to compile conformity documentation that aligns with the RoHS 2 harmonized standard.
For RoHS 2 compliance, manufacturers must carry out conformity assessment based on internal production control procedures that are in conformance with EU Decision 768/2008/EC and EU Regulation 765/2008/EC. The RoHS 2 Directive Article 7(b) specifies:
b) manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;
Products may not be sold on the EU market unless the manufacturer has drawn up the technical documentation.
The RoHS 2 Technical documentation File (TDF) must meet specific requirements
- makes it possible to assess the products' conformity and includes an adequate analysis and assessment of the risk(s).
- Shall specify the applicable requirements for design and manufacture of the product.
To develop a TDF template for your products, please contact us.
For additional information on technical documentation, please visit the "RoHS 2 Technical Documentation" posting in our ECD blog.