European Directive 2011/65/EU (“RoHS Directive”) bans the placing on the European market of any electrical and electronic equipment (“EEE”) that contains more than the permitted level of 6 hazardous substances: lead, mercury, cadmium, hexavalent chromium, PBBs and PBDEs.
From 22 July 2016 in vitro diagnostic medical devices (“IVD”) will come within scope of the RoHS Directive. This means that unless an exemption applies, manufacturers and distributors will only be allowed to market these products if they are RoHS compliant.
Medical devices came within scope of the RoHS Directive in 2014. From 2021, both medical devices and IVDs will also need to comply with the restrictions for the further 4 substances (DEHP, BBP, DBP and DIBP) that will be brought within scope of the RoHS Directive in 2019.
If a product is within scope of the RoHS Directive, then as a manufacturer, importer or distributor, you must ensure that:
- the restricted substances are either not used in the device or are within the maximum permitted concentrations;
- the devices have been through the relevant testing and have the relevant technical documentation;
- a Declaration of Conformity is available and the device is affixed with a CE Mark; and
- you comply with the record retention and register requirements including keeping the technical documentation and declaration of conformity for a period of 10 years after the device has been placed on the market.
You will already be familiar with these types of requirements as part of your compliance with the IVD Directive and other applicable “new approach” directives.
In preparation for IVDs coming within scope of the RoHS Directive, you should:
- Assess whether or not your devices fall within scope of the RoHS Directive. If so, do any exemptions apply?
- Carry out due diligence on your supply chain to ensure that RoHS compliant components are sourced.
- Agree your strategy for dealing with devices that are already in the supply chain.
- Prepare for questions about RoHS compliance from customers.
- Update your Declarations of Conformity.