Brain Products and RoHS compliance – Ro…what?
As manufacturer of hardware products for neurophysiological research, Brain Products confirms “that we fulfil due to design, choice of material/components and production procedures the requirements of the RoHS Directive“. If your purchasing department ever asked for this kind of certificate, let me explain you what it is.
Already back in February 2003, the European Union (EU) adopted the “Restriction of Hazardous Substances Directive 2002/95/EC (RoHS-I)”. RoHS-I took effect on July 1, 2006 and since then constitutes the law in each EU member state.
Are Brain Products BrainAmp amplifiers, electrode caps, accessories, etc.
Under RoHS-I, medical devices were exempted from the requirements as listed above. However, on July 22, 2014 RoHS-II (i.e. Directive 2011/65/EU) came into effect, and since then the above requirements have become applicable to medical devices as well.
Brain Products sells medical devices. Therefore, RoHS-II compliance is required, isn’t it?
With effect from October 7, 2014 all of our products were declared non-medical devices. Beyond this date, RoHS-II compliance does not need to be confirmed.
Products (e.g. BrainAmp amplifiers and accessories) that were sold as new medical devices from July 22, 2014 to October 6, 2014 are subject to an official RoHS-II compliance declaration by the manufacturer.
RoHS-II compliance for electronic products as has been specified in the above section “Other EEE not covered by any of the categories above (‘catch-all category’)” will have to be confirmed by issuing an official RoHS conformity declaration with effect from July 22, 2019. This will take effect on all products manufactured by Brain Products (e.g. actiCAP active electrodes, actiCHamp etc.).
If you would like to request a RoHS-II conformity declaration for any BrainAmp amplifier that was purchased as new medical device (July 22, 2014 to October 6, 2014), please contact qm@brainproducts.com and indicate the serial number of your BrainAmp amplifier.