RoHS, WEEE and REACH Consulting Expertise Needed

[jgdavis]

Working with a client to introduce a next generation of electro-mechanical medical device into the EU. In preparation, we recently had RoHS, WEEE and REACH assessments done by our 60601 testing house. We were surprised at the number of components that failed or are shown at high risk of failing compliance in their final assessment. Many of them because the component supplier could not or would not provide supplier or material declarations. Has anyone faced similar issues? Do you know of an independent consultant that could advise us on next steps? Any help or referral appreciated. Thanks.

 

[normzone]

Don't know if this will help, but for some experienced counsel re those matters we engaged Intertek, since they handle some testing for us.

It's not a low maintenance set of issues, but it comes with the territory.

 

[Tyler C]

Why can't/won't they provide the declarations?

In my experience, if a supplier can't provide the declarations, it is most likely due to a lack of understanding of the legislation. See what you can do to help them get to the point of understanding so they can provide the declarations.

If they are just simply refusing for the sake of refusing, or refusing because their components are non-compliant, I would suggest finding new suppliers (which I know is easier said than done).

 

[Mark Meer]

I agree that, ideally, your suppliers could provide declarations.

But if that's not possible (and changing suppliers is not viable), then your other option would be to find a test-house that can do some material testing.

From what I recall (don't quote me - a long time since I looked into this), that you can get final materials tested using something like Gas Chromatography–Mass Spectrometry (GC-MS), for under $1000. ...this may be cheaper than chasing down suppliers...

 

[jgdavis]

Thank you Mark for your advice - much appreciated.