Compliance Requirements The directive lays out specific compliance requirements for manufacturers

Compliance Requirements

The directive lays out specific compliance requirements for manufacturers, authorized representatives, importers and distributors of products with materials falling under the scope of RoHS. Compliance is demonstrated for electrical and electronic equipment (EEE) when the manufacturer affixes CE marking either to the product itself or its label. If the device required notified body involvement, only one CE marking with the notified body’s four-digit number would be required, provided the product is compliant to the RoHS.

Manufacturers marketing electronic medical devices in the EU are the most substantially impacted in terms of compliance requirements going forward:

• Ensuring that their products comply with Article 4 of the directive, whichstipulates maximum concentration limits of listed hazardous materials;

• Preparing required technical documentation and abiding by internal production control procedures in accordance with Annex II module A of Decision 768/2008/EC—in other words, self-certification;

• Preparing Declaration of Conformity and affixing CE Marking on finished products once compliance has been demonstrated, which means that the manufacturer first confirms conformity to Annex II of the RoHS directive and then prepares a single technical file and EC Declaration of Conformity according to Medical Devices Directive (or In Vitro Diagnostic Devices Directive) conformity assessment procedures;

• Keeping technical documentation and Declaration of Conformity on file for 10 years following commercialization of products;

• Ensuring procedures are in place to maintain the conformity of the series production process;

• Registering all non-conforming EEE and product recalls, and informing distributors of this data;

• Ensuring that products bear type, batch or serial numbers for identification;

• Indicating name, registered trade name or registered trademark and contact address on their products or on documents accompanying their products;

• Ensuring that immediate corrective measures are taken in the event of product nonconformity, or that nonconforming products are withdrawn or recalled, and informing competent national authorities of noncompliance information; and

• Providing all appropriate information to demonstrate EEE conformity upon request from a national authority.