A Closer Look at How the European Directive RoHS2 Impacts the Medical Device Industry

As a manufacturer of electromedical equipment, you have just over a year left to comply with RoHS 2 directive.

22 April 2013

Learn from the lessons of the past. The Consumer Electronics Association has published a report that identified one of the leading causes of financial loss for companies resulting from the original RoHS Directive as the failure to get products re-designed, compliant, and available in time for sale.

As a manufacturer of electromedical equipment, you have just over a year left to comply with RoHS 2 directive. If the process has not been started, then this should be your number one priority. Any non-compliant product, with the exception of active implantables, will be barred from the European Union after July 22, 2014. In fact, devices may need to meet the requirements sooner in response to professional tenders or other customers requesting RoHS 2 compliant medical equipment well before the date of compliance to ensure effective supply of devices for patient treatment. Keep in mind that compliance must be achieved for all CE mark Directives impacting a medical device or the mark must be removed.

The facts speak for themselves. For example, "For the most complex products, testing and validation can take 18 months or more and obtaining approvals…under the Medical Device Directives can take a year more," according to a report prepared by the ERA Technology Limited on behalf of the European commission.

Conformity information must be compiled into a technical documentation file based on requirements outlined in several legislative documents, standards, and industry best practices. Examples of relevant documents include:

  • Directive 2011/65/EU

  • Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

  • Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No339/93

  • EN 62321: 2009, Electrotechnical products – Determination of levels of sic regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers), which is adopted from IEC 62321 (which also may be used)

  • IEC/TR 62476 Ed 1.0, Guidance for evaluation of product with respect to substance-use restrictions in electrical and electronic products

  • IEC 62474 Ed 1.0, Material Declaration for Products of and for the Electrotechnical Industry published March 1, 2012.

So where are your products that are in the RoHS 2 process and what lessons can you share?

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.