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 RoHS2 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.

 

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

 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 1372 370900
S. AMER:
+55 11 2842 0444
APAC:
+86 400 886 9926
EMEA:
+46 8 750 0000
Germany
+49 711 27311 152
UAE
+971 4 317 8777
 

Regulatory Requirements for Medical Equipment