Self certify RoHS/REACH or outsource?

[Given2Fly]

Hi there,

We are currently developing a compact device for onboard data analysis for use in automotive industry. The device will be launched globally starting with US, but I'm curious about the correct approach to be taken regarding RoHS / REACH. From previous experience, we have self certified devices by running ana analysis of the BOM and ensuring there is RoHS/REACH cert available for each component. We would have received certs from the manufacturer of the PCBA(s) so analysis would be on system BOM level only. We would then create a report and sign off and archive as reviewed. That experience was for med device.

My question is .. is this approach acceptable for global launch of a product or will any regions/notified bodies be looking for RoHS/REACH documentation from an approved body / test house?

Many thanks for the help.

 

[Ellpee]

I would also like to know the answer to this question. My company currently has a column in each Bill of Materials for the products, where the column has the title "RoHS", and each item in the BOM says "Yes" in that column. The company doesn't even have a certificate for RoHS compliance for each product, but instead just rely on that the BOM says all items are RoHS compliant. Not sure if this is good enough or not.

 

[CharlieUK]

There's no "it must be done this way" to determine RoHS compliance for the EU.

IEC EN 63000:2018 is the only Harmonised Standard and is used by some other countries.

The route to demonstrating compliance outlined in EN IEC 63000 is composed of four stages:

• Determine the information needed (see below)
• Collect the information
• Evaluate the information with regard to its quality and trustworthiness
• Review the technical documentation to ensure it remains valid.

The "information needed" can be:

Supplier Declarations and/or Contractual Agreements​

AND / OR​

Material Declarations​

AND / OR​

Analytical Test Results​

What you accept depends on the risk of a restricted substance being present and the trustworthiness of the supplier