EU ROHS and GUI Usability Trial Requirements

[QAengineer13]

We are planning to ship a beta unit for GUI usability trial to the EU.

I have 2 question for which I need an answer and a suitable evidence to demonstrate.

1. This instrument is non-sellable/for non-clinical use and has non-rohs parts on board, can we use this for the beta trial in EU for GUI usability test?
2. what are the requirements in EU directive for an instrument of this kind, this is clearly NOT A PERFORMANCE EVALUATION this is more of a GUI usability test for customer feedback

 

[Ronen E]

Re: EU ROHS and Usability trial requirements

RoHS and the MDD relate to products placed on the market.
The evidence is in the directives. They say so.

 

[shimonv]

Re: EU ROHS and Usability trial requirements

The RoHS Directive (2011/65/EU), Article 2, section 4(j) says that the directive does not apply to: "equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis."


-Shimon

 

[QAengineer13]

Re: EU ROHS and Usability trial requirements

RoHS and the MDD relate to products placed on the market.
The evidence is in the directives. They say so.

Hi Ronen,

Could you please direct me to the article reference in 2011/65/EU and in 98/79/EC , if you don't mind.

 

[QAengineer13]

Re: EU ROHS and Usability trial requirements

The RoHS Directive (2011/65/EU), Article 2, section 4(j) says that the directive does not apply to: "equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis."


-Shimon

Hi Shimon,

Does that mean we should be ok for non-compliance to the ROHS directive?

 

[shimonv]

Yes, I believe so. The RoHS directive is applicable for commercial products.
What you are doing is a trial / research activity and per the Directive it is exempt from the RoHS requirements.
You should mark the device accordingly ("Research only / Not for human use") and retrieve it in the end of the trial.

Shimon

 

[QAengineer13]

Re: EU ROHS and Usability trial requirements

Hi Ronen,

Could you please direct me to the article reference in 2011/65/EU and in 98/79/EC , if you don't mind.

Hi Ronen,

I did my homework, As Shimon pointed out we are excluded from the ROHS From 98/79/EC , (Point 11) and Point (8) gave me some clarity.

I believe we need too comply to EMC.

Thank you Ronen and Shimon for your help!

 

[QAengineer13]

Yes, I believe so. The RoHS directive is applicable for commercial products.
What you are doing is a trial / research activity and per the Directive it is exempt from the RoHS requirements.
You should mark the device accordingly ("Research only / Not for human use") and retrieve it in the end of the trial.

Shimon

Hi Shimon,

Where can i find the labeling requirement for Research unit in the directive?

 

[Ronen E]

Re: EU ROHS and Usability trial requirements

Hi Ronen,

I did my homework, As Shimon pointed out we are excluded from the ROHS From 98/79/EC , (Point 11) and Point (8) gave me some clarity.

I believe we need too comply to EMC.

Thank you Ronen and Shimon for your help!

You're welcome.
As far as I remember the EMC directive (if that's what you meant) also applies only to products being placed on the market.

 

[Pads38]

Where can i find the labeling requirement for Research unit in the directive?

To be clear - the EU MDD does not have any reference to a "Research Only" category of devices.

The closest to 'special' labelling for this purpose might be that shown in Article 4 paragraph 3.

"These devices shall not bear the CE marking.
3. At trade fairs exhibitions demonstrations etc....provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply."