Sunday, 20 April 2014


Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

As of July 22, 2014, most powered equipment sold within the European Union (EU) must not contain more than the allowed quantities for each homogeneous material listed below: 
  • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

Homogeneous material means one material of uniform composition throughout or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, and abrasive processes. This is somewhat frightening, as even small electronic parts could be “ground” into a variety of homogeneous materials.

Although RoHS has been in effect since February 2003, this is the first time that it has applied to medical devices. There are a few exceptions: pacemakers, certain types of sensors, and some parts of X-ray equipment.

What makes RoHS such a particularly unique concern to the medical device industry is that RoHS has never been applied to a group of products manufactured in factories already under annual surveillance as per Medical Device Directive 93/42/EEC. Most medical devices manufacturers are subject to regular audits of their quality system under this directive. RoHS pertains to quality systems as well, so medical device manufacturers could experience some of the most dramatic enforcement of any industry or product group, if the notified bodies are activated to assess RoHS compliance during their annual audits.

Doing Your Due Diligence

Not surprising, spot inspections by EU authorities have raised concerns about the efforts of some manufacturers to meet the RoHS directive’s obligations. In some instances, electronic equipment manufacturers had adopted a “lead free” perspective (presuming that switching to lead-free solder would be enough). Quite clearly the directive includes no less than six substances of concern, and many manufacturers were not examining all the parts, down to the homogeneous-material level to ensure they conformed to the directive.

The RoHS directive’s previous version had been in place for eight years, and electronic parts manufacturers are only now getting rid of banned substances. One would hope that the marketplace for electronic parts used in medical devices is much safer.

RoHS is an absolute; you must not be in violation of the directive, even accidentally, or you risk serious legal consequences. To balance the scales a bit, the concept of due diligence has been proffered, wherein a company might show that it took all reasonable steps to avoid committing the offence. Due diligence is demonstrated by having internal procedures for screening all parts of an electronic device against the restricted substances (which also includes the nuts and screws that hold them together).

There are a number of places on the web to find information on how to meet “RoHS 2” as it is called. There are also laboratories and companies set up to help determine whether a part has too much of the restricted substances.

The best place to begin screening your products is with your part supplier’s own declarations of RoHS compliance. By process of elimination, you can then determine if testing a part is necessary, or whether replacing it with an obvious RoHS alternative is possible. In certain instances, if it is impossible to make a device without including a banned substance, it is possible to successfully petition for an exemption.

The RoHS compliance deadline for manufacturers of electrically powered medical devices is July 22, 2014. It is a challenging and labour-intensive process to make sure a product complies, but it has become much easier. By readying your company to show due diligence to your auditor by July 22, 2014, you can be sure of steady market access to Europe.

Source: Grant Ramaley, Quality Insider.

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