REACH compliance with MDR

#1
Hi, I'm new here and I'm trying to find more information about this case, we're basically selling a small electronic medical device (non invasive) and I'd like to know more about the requirements for REACH compliance, I'm a bit confused as to where to start. Currently CE marked and selling under MDD certificate but we eventually want to comply with MDR.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Welcome LuciusC!

REACH is a regulation from the European Commission. Read the links in their web page for more details.

Compliance is usually established through certificate of conformance obtained from raw material suppliers who are capable of performing or obtaining testing of those raw materials in order to verify their content does not include the covered substances.

I hope this helps.
 

planB

Super Moderator
#3
LuciusC,

also your currently CE marked MDD device has had to comply with REACH. Some questions for clarification: are you a manufacturer within the EU? Do you source materials or components from inside or from outside the EU?
 
#4
LuciusC,

also your currently CE marked MDD device has had to comply with REACH. Some questions for clarification: are you a manufacturer within the EU? Do you source materials or components from inside or from outside the EU?
No not withing the EU, and yes we source from outside of EU as well as inside

Thank you
 

planB

Super Moderator
#5
One way to establish REACH compliance might be to collect REACH certificates for each article from your all suppliers. Since articles sourced from the EU have to comply to REACH upfront, you could spare this activity for these.
 
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