What You Should Know: Medical Device Manufacturer's Responsibility and RoHS 2

Did you know RoHS 2 is a CE mark directive? Learn more in today’s blog.

24 April 2013

As of July 22, 2014, when you place a CE mark on each of the medical devices covered, you are confirming that all appropriate measures have been taken to ensure each product meets the RoHS 2 directive, including conformity assessment, as well as meeting the requirements of all relevant CE Directives. The conformity assessment to RoHS directive needs to include a process demonstrating that the medical device does not contain any of the restricted substances – unless it is an active implantable or critical to an implantable device's operation.

It is the sole responsibility of the medical device manufacturer to compile the "technical file" that enables RoHS 2 assessment of conformity of the product. This means considerably more work for manufacturers, suppliers and importers regarding the documentation and monitoring of medical devices - requiring a continuous exchange of information in the entire supply chain. For example, a Restricted Substance Control (RSC) Process must be implemented, which includes collecting compliance data for every component of material in the design. This documentation must be included in the technical file, and be kept available for ten years after the product has been placed in the market.

Examples of documents included in a RoHS 2 technical file are:

  • conformity risk assessment

  • supplier declarations of compliance

  • materials declarations

  • results of supplier audits

  • chemical analysis results

  • explanations of why test reports are not included, when absent

How is your organization addressing the RoHS 2 compliance challenges?

Today's expert is Joe Langton, Senior Consultant and Program Manager within Intertek's Health, Environmental and Regulatory Services unit. For the past five years, he has provided comprehensive compliance solutions related to the RoHS Directive, Restricted Substances, CPSIA, REACH, End of Life Management and Electronics Recycling, Environmentally Preferable Materials, and California Proposition 65. Joe is based out of the Allentown, Pennsylvania office.