RoHS for Medical Devices - "Medical Device Exception"

[Steve McQuality]

We were recently solicited by a customer to provide information on our RoHS compliance status. I've solicited most of our electronic component vendors for this customer for information regarding their components, and on the last inquiry it was relayed to me that "Medical Devices" are exempt from RoHS until 2010. That OBVIOUSLY sparked my interested (to say the least), so I went back to 'Google' and found many references to this fact - but all from "manufacturers" as far as I could tell; nothing "official".

What I'm looking for is a definitive reference from an "official" EU organization regarding RoHS and the related "Medical Device Exception" that I can "Quote" to our customer and let them know that this is the case and that we've got a couple years left to "get our ducks in a row". Can anyone point me to an "offical" reference to this fact?

I know this is the wrong time to ask this question (3:21 on a Friday afternoon!) but maybe on Monday??? Any Cover's that can help out there???

[Al Rosen]

Originally Posted by Steve McQuality

We were recently solicited by a customer to provide information on our RoHS compliance status. I've solicited most of our electronic component vendors for this customer for information regarding their components, and on the last inquiry it was relayed to me that "Medical Devices" are exempt from RoHS until 2010. That OBVIOUSLY sparked my interested (to say the least), so I went back to 'Google' and found many references to this fact - but all from "manufacturers" as far as I could tell; nothing "official".

What I'm looking for is a definitive reference from an "official" EU organization regarding RoHS and the related "Medical Device Exception" that I can "Quote" to our customer and let them know that this is the case and that we've got a couple years left to "get our ducks in a row". Can anyone point me to an "offical" reference to this fact?

I know this is the wrong time to ask this question (3:21 on a Friday afternoon!) but maybe on Monday??? Any Cover's that can help out there???

The scope of the ROHS directive does not include category 8 of annex IA of the weee directive. Category 8 is Medical Devices. I've attached both directives in, "Is RoHS just for the electronics industry?" You can verify this for yourself from the directives. Just follow the convoluted road.

[Steve McQuality]

Convoluted - to say the least!

I've been reading these documents and supporting documents and such off and on for about a week - the three documents you attached in the referenced thread (especially the "RoHS Expemption.pdf") was definitely the "sunshine that cleared the fog"!

I think I can pull the correct sections from these documents and put together an internal memo that outlines the "current" position regarding medical devices. I've seen the references to excluding "8 & 9" of the WEEE in RoHS, but couldn't pull this together until now - THANK YOU AL!!

You've done it again, dear Watson - this was the guidance (and interpretation) I was looking for. If you keep helping me like this, I'm going to have to solicit HR to put you on our payroll!!