Recast of EU’s Hazardous Material Regulations to Impact Medical Devices

The European Union’s Restriction on Hazardous Substances (RoHS) Directive covering electronic devices will soon also cover medical devices.

The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.

According to a Massdevice.com report, medical devices and IVD products had previously been exempted from the RoHS, but that exemption will not be extended except for active implants. As such, medical devices and monitoring and control instruments will have three years to comply with RoHS following the directive’s adoption; IVD products will have five years to comply.

The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.

The European Parliament adopted the text of the RoHS recast late last year; MassDevice.com cites reports from BSI that final approval of the law is imminent.

The RoHS currently restricts lead, mercury, cadmium, hexavalent chromium, PBB and PBDE; according to BSI, the directive’s list of restricted substances is likely to expand. 

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