IVDD RoHS Directive Compliance to 2011/65/EU

[dr1vn]

So, if I am making an IVDD I understand that I have until July 22, 2016 to get to compliance to the new RoHS directive. I asked my suppliers if they are compliant to the new directive, but they all insist that since there are no changes between the old (2002/95/EC) and new directive with respect to the restricted substances that they do not need to be certified to the new directive. Any thoughts on how to resolve this? Would it be okay to collect the different suppliers RoHS (2002/95/EC) compliance and then write up some gap analysis document that we are 2011/g5/EU compliant?

 

[sreenu927]

If your suppliers are providing the components, then they will give you a revised certificate stating that particular component is compliant to ROHS new Directive.

If you are finished goods manufacturer (assume so!), then you will provide that the ROHS Compliant Certificate/symbol into your instrument documentation and ship to customers.

If there is no difference between the old and latest RoHS Directive, you need to make sure that your suppliers have performed the gap analysis and ensured no action is required other than the update of current RoHS Certificate.

Regards,
Sreenu

 

[dr1vn]

Thanks. I figured what you said is the case. However, the suppliers that are providing the components we need are not compliant with the new RoHS and are saying that the are not going to be (weird, right?).

I think I will proceed as normal and just include a gap analysis in my own documentation that says the components of the finished device meets the technical requirements of the old standard and so it is therefore compliant with RoHS 2...

Has anyone dealt with suppliers that say they will not be compliant with RoHS 2?

 

[drewsky1]

Does anyone know if the ROHs applies to products in US and other international markets as well as EU?

Thanks

 

[bio_subbu]

Does anyone know if the ROHs applies to products in US and other international markets as well as EU?

Thanks

In US, the Environmental Design of Electrical Equipment Act (EDEE) Act “H.R. 2420” was introduced as a Bill in the US House of Representatives on May 14, 2009 (the Bill currently sits with the Committee on Energy and Commerce waiting for approval).

The EDEE Act states that no electro-industry product shall be manufactured / imported after 1st July 2010 that contains a concentration value greater than 0.1 percent (10%) by weight of lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE) as measured in any homogenous material contained in the electro-industry product. The substance restrictions and maximum permitted concentration values are the same as compare with EU RoHS recast (2011/65/EU).

The EDEE Act will be implemented as an amendment to the Toxic Substances Control Act (TSCA) of 1976. According to the H.R. 2450, the definition of “Electroindustry products” means;

ELECTROINDUSTRY PRODUCTS .—As used in subsection (e), the term electro industry product ‘means any product or equipment that is directly used to facilitate the transmission, distribution, or control of electricity, or that uses electrical power for arc welding, lighting, signaling protection and communication, or medical imaging, or electrical motors and generators, and applicable to products or equipment designed for use with a voltage rating of 300 volts or above.

As regards to medical devices, the following informations are citied in H.R 2450;

‘‘(v) medical diagnostic imaging and therapy equipment and devices, communications and emergency call systems and products, modular walls, consoles, systems, products, panels, meters, and monitors used in healthcare facilities".

In US, few states have already implemented state-level RoHS type restrictions. eg.. California has implemented as laws that restrict use of certain non-RoHS products.