Is REACH applicable to Medical Devices in the EU?

T

Tiffany

#1
Hi Mates,

REACH is applicable to Medical Devices?

I am confusing is that all the Medical Devices Manufacturers put the product into EU is subjected for this regulation?

How is the implementation should be put in place for my company as the medical devices manufacturers?

Thanks

Tiffany
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: REACH for Medical Devices

Hi,

If you are not a manufacturer of substances and are located outside the EU, then REACH probably has low applicability to you.

To determine your obligations (if any) and find guidance, you could try here:

http://echa.europa.eu/reach/reach_faq_en.asp

If you're still confused - come back and share...

Cheers,
Ronen.
 
J

jayquality

#3
Re: REACH for Medical Devices

for medical devices, article 33 of reach (european directive 2006/1907/EG) is applicable
this means you have to inform your customers of any substances that are on the candidate list of Substances of Very High Concern (SVHC)

basically you research your BOM and identify any substances used
then make a reach statement declaring whatever substance is used

if you use power cables or other cables, chances are they use DEHP as plasticizer

example letters can be found from dell, hp and many others

i used a form that i send to suppliers of parts to inform us about any substances and made up a statement for our customers

many ignore this and tell use reach is not applicable but when we explain about article 33 they come up with statement, just have to push them to go up their chain
 
T

Tiffany

#4
Re: REACH for Medical Devices

Hi,

What if one of the chemicals used in the preparation is one of the chemical listed in the SVHC? As this chemicals is commonly used in the preparation of this product, wondering how it could having the impact to our competitors?? And so far never heard the competitor having this concern as it seems being long time supplying into EU market!

If this chemicals is in the SVHC, mandate to report and notify EU and how should we go about it??

Thanks....

Tiff
 
J

jayquality

#5
Re: REACH for Medical Devices

if you dont import or produce the chemicals you only have an information duty towards your customers or downchannel
 

jradford

Involved In Discussions
#6
Re: REACH for Medical Devices

But then article 60-Granting of authorisations says:

The Commission shall not consider the risks to human health
arising from the use of a substance in a medical device regulated
by Council Directive 90/385/EEC of 20 June 1990 on the
approximation of the laws of the Member States relating to
active implantable medical devices (1), Council Directive 93/42/
EEC of 14 June 1993 concerning medical devices (2) or Directive
98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices (3).

Ultimately I need to keep a list of anything on the critical components list and create a declaration that we do not exceed 0.1% w/w and do not import 1 ton of any of the critical components just to be safe?
 
D

drewsky1

#7
Re: REACH for Medical Devices

If I understand REACH correctly, it is not applicable to mfrs, suppliers outside of the EU as it only applies to products being produced in-country in the EU and not for other countries that may produce outside of EU and distribute to EU. Is this correct?
 
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