RoHS for Medical Devices - Does the directive apply to non-EEE accessories?

R

Riskcord

#1
Hi all,

I work for a medical device company and we are currently revising and updating our products for RoHS compliance as, as you most likely know, the exemption for compliance for medical devices will expire in July next year.

There is one item which I don't find as clearly defined in the directive 2011/65/EU and relates to requirements for accessories.

My question would be: do non-EEE accessories of EEE medical devices fall under the scope of the directive? In our case, we manufacturer devices that are use for surgery and they make use of a number of disposables (tubing, tools for surgery preparation, etc.).

For the definition of medical device, the directive points to point (a) of article 1(2) of the directive, 93/42/ECC. Point (b) of the same articles defines an accessory as a medical device, however there is no mention to this point (or to accessories in general) on the 2011 directive. Plus, the new directive clarify that in order to fall under the scope, it must be a medical device AND EEE.

Any ideas on this?
Thanks.
 
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bio_subbu

Super Moderator
#2
Hi all,

I work for a medical device company and we are currently revising and updating our products for RoHS compliance as, as you most likely know, the exemption for compliance for medical devices will expire in July next year.

There is one item which I don't find as clearly defined in the directive 2011/65/EU and relates to requirements for accessories.

My question would be: do non-EEE accessories of EEE medical devices fall under the scope of the directive? In our case, we manufacturer devices that are use for surgery and they make use of a number of disposables (tubing, tools for surgery preparation, etc.).

For the definition of medical device, the directive points to point (a) of article 1(2) of the directive, 93/42/ECC. Point (b) of the same articles defines an accessory as a medical device, however there is no mention to this point (or to accessories in general) on the 2011 directive. Plus, the new directive clarify that in order to fall under the scope, it must be a medical device AND EEE.

Any ideas on this?
Thanks.
Non- EEE accessories are not fall in the scope of the RoHS recast as they are not electric or electronic equipment. Even if they have some electric or electronic components, they are not to be considered EEE according to the definition of Article 3(1) of DIRECTIVE 2011/65/EU.

Article 3(1)

?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;"
 
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