What needs to be done to demonstrate RoHS compliance for Medical Devices?

SGquality

Quite Involved in Discussions
#1
Pls help me understand what needs to be done to demonstrate compliance to RoHS Compliance for Medical devices ?

Also, is this applicable only for devices sold into Europe ?
 
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andka907

Involved In Discussions
#2
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

Hi try to give you some help however I am no expert in the field but there are extensive information on the internet.

Please check the Blue guide
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf

Page 102 pp for flow chart what is required for Medical devices - the details of technical documentation you'll find somewhere else

RoHS is a EU directive hence applies to EU countires.
.
 

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bio_subbu

Super Moderator
#3
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

Pls help me understand what needs to be done to demonstrate compliance to RoHS Compliance for Medical devices ?

Also, is this applicable only for devices sold into Europe ?
Hi

RoHS stands for ?Restriction of Hazardous Substances and regulates the use of certain hazardous substances? in electronic equipment. The RoHS Directive is fully implemented in Europe, and aims to restrict certain dangerous substances commonly used in electronic and electronic equipment.

RoHS I Directive (2002/95/EC) restricts the use of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls and polybrominated diphenylethers in certain electrical and electronic equipment since 1st July 2006. RoHS I Directive (2002/95/EC) has been replaced by RoHS II ?Directive 2011/65/EU? and published in the Official Journal of the EU on 1st July 2011.

RoHS II ?Directive 2011/65/EU? maintains the same substances subject to restriction of RoHS I. However, RoHS recast Directive extends them to medical devices which are placed on the market from 22nd July 2014 and to invitro diagnostic medical devices which are placed on the market from 22nd July 2016.

If your medical equipment considered as ?EEE? according to the definition of Article 3(1) of Directive 2011/65/EU, you may want to comply with RoHS recast Directive requirements.

?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;"

For more understanding, refer below EU Commission webpage, the link points to the where you can download an FAQ paper, which is not specific to Medical Devices but could provide you additional information..

http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm
 

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somashekar

Staff member
Super Moderator
#4
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

Pls help me understand what needs to be done to demonstrate compliance to RoHS Compliance for Medical devices ?

Also, is this applicable only for devices sold into Europe ?
Does your medical device already carry a CE mark... and is notified with a NB...
I assume so.
I may be a bit different but this must work for you.
RoHS is applicable to EEE Medical devices.
It is a CE mark directive.
RoHS compliance will have to be demonstrated through a technical file, that the NB reviews and approves to continue use of CE mark
There will be only one CE mark and you have it already .... :)))
Ask your NB how he would want the Technical file to be updated to contain RoHS information and RoHS test certification, and follow guidelines provided by the NB. Make your RoHS declaration as given in the new directive and include it in your technical file.
As far as possible and practicable, get your suppliers to declare the supplied parts as RoHS in line with the declaration that you find in the new RoHS directive, and make this a part of your technical file. Make a risk based assessment to get any parts tested yourself and include same in the technical file.
If you have planned well, you are not far from being good within the 2014 timeline.... Cheers :agree1:
 

SGquality

Quite Involved in Discussions
#5
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

Soma,

Per RoHS II, it is applicable for new devices placed on market as on Jul 22, 2014. Does that mean the already existing products in market need not be covered under RoHS ?
 

somashekar

Staff member
Super Moderator
#6
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

The time available now till July 2014 is the transition time for understanding, applying assessing and declaring.
 
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bio_subbu

Super Moderator
#7
Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?

Soma,

Per RoHS II, it is applicable for new devices placed on market as on Jul 22, 2014. Does that mean the already existing products in market need not be covered under RoHS ?
The RoHS Directive applies to products at the moment they are placed on the EU market. Products placed on the market before July 2014 (Medical devices) which are not compliant can remain on the market and can be sold, rented, leased, etc until the end of their lives.

Importation of products is always considered a placing on the market, therefore after July 2014 it is not possible to import non RoHS compliant products in EU regardless of the date they were manufactured or sold.
 
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