R
Riskcord
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.
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.