EU restrictions impacts medical devices

Pablo Valerio

June 16, 2017

Pablo ValerioJune 16, 2017

By July 22, the third phase of the RoHS 2 directive will take effect. The rule, part of the Directive 2011/65/EU of 2011, directly affects the import, manufacture, and sale of medical devices in the European Union (EU). New products that do not comply with the Directive’s restrictions on hazardous substances won’t be allowed to be sold in the EU.

RoHS 2 is a recast of the earlier RoHS Directive 2002/95/EC (RoHS 1). Both RoHS directives have stimulated a reduction in hazardous materials all over the world: several countries, including China, Korea and the US, have developed RoHS like legislation.

Because of medical equipment’s complexity and use of banned substances such as lead for radiation shields, the EU has granted some exemptions to the rules, especially for devices already in the market, which are outside the scope of RoHS 1 but non-RoHS 2 compliant and require maintenance and spare parts to continue operation.

The European Commission, however, is warning all stakeholders in the medical industry that in less than two years no secondary market of non-RoHS 2 compliant devices will be allowed. All medical equipment bought after 21 July, 2014, outside the scope of RoHS 1 but containing substances banned by RoHS 2 could still be refurbished by a manufacturer-authorized facility until 22 July, 2019. After that date, however, recirculating those products will be an infringement of the Directive due to the hard-stop of secondary-market operations.

The problem is that high-end medical devices are designed to last for years, with a life of 10 or more. During that period they are repaired, with suitable spare parts, and eventually retrofitted and resold to another customer. Without this secondary market possibility, the investment in new equipment could be prohibitive.

Continue reading on Embedded's sister site, EBN: "Medical devices & other EEEs could face Hard-Stop in EU by 2019."

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