The Status of ROHS for Medical Devices - April 2019

DRA

Starting to get Involved
#1
Hi,

Can any one resolve my queries as below
1. Whether ROHS 2 is made obsolete.​
2. Whether ROHS 3 got released​
3. Whether all the requirements of ROHs 1 & 2 or incorporate in ROHs 3?​
4. As a medical device manufacturer which ROHS rev I need to show compliance against EU MDR?​
need clarification on above questions
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

Can any one resolve my queries as below
1. Whether ROHS 2 is made obsolete.​
2. Whether ROHS 3 got released​
3. Whether all the requirements of ROHs 1 & 2 or incorporate in ROHs 3?​
4. As a medical device manufacturer which ROHS rev I need to show compliance against EU MDR?​
need clarification on above questions
1. "RoHS 2" (2011/65 or RoHS recast) is not made obsolete. "RoHS 3" (2015/863) is an amendment to Annex II of 2011/65.
2. 2015/863 was published in 2015 and is coming into force in July 2019. However, for medical devices the four additional restrictions will only apply from July 2021.
3. Refer to my answer 1 above.
4. The MDR and RoHS (2011/65 as amended by 2015/863) are independent of each other and you need to comply with both.

RoHS: Additional restricted substances
 
#3
Hi,

About the Medical devices, how does this relate to the new MDR? In " RoHS 2" directive they refer to Council Directive 93/42/EEC which will become obsolete after May 26, 2020. Within the MDR I don't see a reference to the current RoHS directive.

Can you explain me where to find this?

Thanks!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

About the Medical devices, how does this relate to the new MDR? In " RoHS 2" directive they refer to Council Directive 93/42/EEC which will become obsolete after May 26, 2020. Within the MDR I don't see a reference to the current RoHS directive.

Can you explain me where to find this?

Thanks!
I don't see where the problem is.
2011/65's references to 93/42/EEC are not not numerous and not substantial and I think you could safely treat them as redirected to 2017/745 (the MDR).
As above, both RoHS and medical devices regulation come under the "New Approach" (that covers CE marking) and are independent of each other - refer to the Blue Guide 2014.
 
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