Medical Devices & Other EEEs Could Face Hard-Stop in EU by 2019

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.

The European Commission expressed concern in a recent assessment report that this legal constraint would shorten the lifetime of many products and possibly create a parallel market for repairs outside the official channels.

To address these concerns and after evaluating thousands of exemption requests, the Commission has recommended to the European Parliament a series of amendments to the RoHS directive. These include an exemption for certain categories of medical devices, extending the deadline for secondary market operations to 2021.

If the EU Parliament grants the Commission’s request, as it normally does, it will allow medical devices outside the scope of RoHS 1 (Directive 2002/95/EC) to continue being repaired and resold within the EU during their operating lifetime.

One interesting RoHS exemption requested by the Commission is for pipe organs. Apparently, after July 2019, the Directive could cause the de-facto prohibition of pipe organs deliveries on the EU market, as the pipes would not be RoHS-compliant due to the lead used to produce the desired sound. After several consultations with manufacturers and users, it has been determined that there is no suitable substitute for lead in the alloy that produces the required sound. The Commission is thus requesting that pipe organs be granted a full exemption.

The whole electronics industry should be aware that, despite the proposals from the Commission, secondary market operations of non-RoHS compliant products will face a hard-stop on July 22, 2019. According to the Directive, this will affect “medical devices and monitoring and control instruments, which are placed on the market from 22 July 2014, in vitro diagnostic medical devices which are placed on the market from 22 July 2016, industrial monitoring and control instruments which are placed on the market from 22 July 2017 and all other EEE that was outside the scope of Directive 2002/95/EC which is placed on the market from 22 July 2019.”

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