RoHS compliance - Our market is non EU countries only

#1
Hi,

Can someone kindly help me in this? We manufacture class I medical device which has CE mark. It is not RoHS compliance. Our market is non EU countries only and we don't have any plan to export to UK.

Is it still required to be RoHS compliance as the product have CE mark?.
 
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bio_subbu

Super Moderator
#2
Hi,

Can someone kindly help me in this? We manufacture class I medical device which has CE mark. It is not RoHS compliance. Our market is non EU countries only and we don't have any plan to export to UK.

Is it still required to be RoHS compliance as the product have CE mark?.
Hi Amrita Bhat

The RoHS recast Directive (2011/65/EU) is now a new approach Directive with CE marking.

What is the intended use (product claim) of your product?. Is your medical device fall under the category of EEE (Electrical and electronic equipment)?, if so, you have to comply with RoHS recast directive 2011/65/EU.

Definition of EEE per Article 3.1 of 2011/65/EU:

“electrical and electronic equipment” or EEE means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;"


Also you refer the existing thread "ROHS and CE Mark - Requirements for a Class IIa Medical Device"
 
#3
:thanx:

We have three components in our product. The component used with patient does not come under EEE. The component falling under EEE category is used only for heating purpose, it never used with patient.

Can I give above justification for not meeting.

I know we have to have compliance that we are taking care, this is the question for present stock manufactured after June 2014
 

Pads38

Trusted Information Resource
#4
Where a product may be classified under several CE marking directives (perhaps MDD, RoHS, EMC, LVDD) the Deceleration of Conformity needs to be specific about which directives apply to which devices.

The DoC can be copied into the Operators Manual and can be a "publicly available" document, either by request or even on the web.
 

somashekar

Staff member
Super Moderator
#5
:thanx:

We have three components in our product. The component used with patient does not come under EEE. The component falling under EEE category is used only for heating purpose, it never used with patient.

Can I give above justification for not meeting.

I know we have to have compliance that we are taking care, this is the question for present stock manufactured after June 2014
Your CE which is a self declaration is perhaps only towards MDD.
Class I and so there is no NB involved.
When the country you intend to supply do not require RoHS, and your D of C is clear about that, not being RoHS compliant will not stop you from selling in that country.
A CE mark by default does not proclaim RoHS OK....
 
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