RoHS 2 Product Compliance for Medical Devices

EU RoHS 2 Directive 2011/65/EU

Through training, testing and certification, Intertek’s team of medical product compliance experts can help you define and develop your product’s technical file content and process controls to ensure your device meets the requirements of the RoHS 2 Directive.

Exemptions list to EU RoHS 2 Directive 2011/65/EU

In effect since July 21, 2011, RoHS 2 identifies six regulated substances - lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ether - restricted in manufacturing certain electrical and electronic equipment sold in the EU. The scope of the Directive extends to all electrical and electronic equipment within 11 broad categories, including:

• Medical Devices (excluding in vitro) - Comply by July 22, 2014
• In vitro Diagnostic Devices - Comply by July 22, 2016

Partner with Intertek to learn more about making strategic decisions for medical product compliance.

• On-site Training, Education & Consulting
• RoHS 2 Responsibilities and Supplier Assessment
• Review of Technical File Documentation
• Bill of Material (BOM) Assessment
• Analytical Testing (IEC 62321)
• Compliance Review/Audit
• CE Marking for Medical Devices

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.