RoHS Compliance for a Medical Device Manufacturer

[Bunny]

I work for a medical device manufacturer in the US, we want to sell our product into Europe and need to get a better understanding of RoHS and WEEE regulations. I have looked at this site and found some relevant threads and documents. But I was wondering if there was more to know. Especially regarding medical device compliance. Is it true that medical devices do not yet have to comply?

Can someone help me understand what medical device manufacturers have to do to demonstrate compliance? Can someone provide useful tips about how we can implement a process that ensures we RoHS compliant components? Do we need a COC with each receipt of electronic components?

Thank you in advance.

 

[somashekar]

I work for a medical device manufacturer in the US, we want to sell our product into Europe and need to get a better understanding of RoHS and WEEE regulations. I have looked at this site and found some relevant threads and documents. But I was wondering if there was more to know. Especially regarding medical device compliance. Is it true that medical devices do not yet have to comply?

Can someone help me understand what medical device manufacturers have to do to demonstrate compliance? Can someone provide useful tips about how we can implement a process that ensures we RoHS compliant components? Do we need a COC with each receipt of electronic components?

Thank you in advance.

Hii Bunny.
As I understand it is true that medical devices do not yet have to comply.
You may want to look into www.bomcheck.net and understand more.

 

[Jonazzz]

Originally Posted by Bunny


I work for a medical device manufacturer in the US, we want to sell our product into Europe and need to get a better understanding of RoHS and WEEE regulations. I have looked at this site and found some relevant threads and documents. But I was wondering if there was more to know. Especially regarding medical device compliance. Is it true that medical devices do not yet have to comply?

Can someone help me understand what medical device manufacturers have to do to demonstrate compliance? Can someone provide useful tips about how we can implement a process that ensures we RoHS compliant components? Do we need a COC with each receipt of electron components?

Thank you in advance.

In the current RoHS directive 2002/95/EC Medical Devices and Control Equipment are excluded from the RoHS scope (Categories 8 & 9 as defined within the WEEE directive).
In other words, yes you do not have to comply with the current RoHS restrictions yet.

BUT, currently the European Parlement is preparing a recast for RoHS, which is expected to come into force in 2012.
Currently the idea is that the recast will also include Medical Devices and Control Equipment.
So maybe you want to prepare yourself already for this recast.

Nevertheless, if you want to find out more about RoHS and the recast, please visit:
http://ec.europa.eu/environment/waste/weee/legis_en.htm

Here you can find all the official documents.

Originally Posted by somashekar
Hii Bunny.
As I understand it is true that medical devices do not yet have to comply.
You may want to look into www.bomcheck.net and understand more.

With regards to BOMcheck... this application has been developped by SIEMENS and Environ and is more related to the REACH legislation than to RoHS.
I'm not saying that BOMcheck will not be able to cover RoHS as well, because there is a RoHS module in it, but BOMcheck is a "supplychain communication tool" but it will not give you the official documents on RoHS.

I guess that with the information that you will find on the official Eu website, you will find all necessary answers.

 

[Bunny]

I think I have all the required regulations. Now I have to obtain the RoHs certificates and create the policy documents.

 

[Bunny]

Will we need to register in the EU if we sell product there?

 

[Jonazzz]

Will we need to register in the EU if we sell product there?

To be honest, I don't know what kind of registrations you would need, from a commercial perspective I mean, to be able to sell your product into the EU market.
I do know that a lot of safety regulations are also applied, like CE marking, Low Voltage directive and many more other requirements.

When it comes down to RoHS, there is nothing to register yourselve for. You just need to make sure you comply with Eu laws and directives.
Like I already mentioned, currently Medical Devices are out of scope for RoHS.

But when you mention "Registration", often this terminology is related to the "REACH" legislation, that came into force on June 1st, 2007.

If you want to know more about this "REACH" legislation, I suggest that you explore this forum a bit more, and come back with your questions to us.
What I already can tell you, is that for sure these Medical Devices are NOT excluded from the REACH legislation.

 

[MIREGMGR]

Will we need to register in the EU if we sell product there?

Quoting from an earlier post:

I work for a medical device manufacturer in the US, we want to sell our product into Europe

Are you asking about registration in regard to RoHS/REACH, or medical device marketing in general?

 

[Bunny]

I am asking about RoHS registration. I saw something on the web about registering in the UK. I will poke around this forum some more looking for REACH topics.

 

[Bunny]

REACH does not apply to me. We do not manufacturer chemicals.

 

[Bunny]

I am in the process of establishing an in-house system to ensure RoHS compliance as it relates to our purchasing and incoming inspection processes.

Do I need to concern myself with hardware (nuts, screws, etc) and sheet metal? I am assuming that I can remove those items from the project scope along with other non-electrical parts. But, I wanted confirmation.