The Manufacturer's Checklist: The Sale of Medical Devices into the European Union

In reality, is RoHS 2 truly enforceable and what do manufacturers need to know? Keep reading in today’s expert blog post.

26 April 2013

Europe is getting serious about its environmental protection and it will be soon be nearly impossible for medical device manufacturers to sell their products into the European Union without full compliance—something that is also now catching on in China, Japan, India and other nations are part of a larger trend toward increased environmental regulation worldwide. So you can be assured the authorities will be reviewing technical files for RoHS 2 compliance beginning July 22, 2014.

Each European state retains the responsibility for enforcing the rules under RoHS 2. The CE Mark directive places more data collection work on distributors and importers as they seek to verify RoHS compliance. In most cases, manufacturers are responsible for documentation and CE Mark designation, but in some instances the responsibility falls to the distributor or importer, especially when the distributor is selling the product under its own brand. In case of suspected non-conformity, manufacturers, distributers, and importers must inform the relevant national enforcement authority. This can lead to corrective measures or returns and recall along with subsequent fines.

You can be certain that environmental regulation is here to stay and will become more stringent in the future given that there is:

  • pending RoHS legislation in China

  • New U.S. rules surrounding conflict minerals sourcing

  • varying state-level bans on certain chemicals in the United States,

  • simmering concern over the supply of rare earth minerals commonly used in electronics equipment

So what other questions do you have related to this topic?

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.