RoHS and placing on the market in Non EU countries

#1
Does anyone have a view on whether it is possible to continue to place on the market non RoHS compliant CE marked product produced prior to 22 Jul 2014 in non-EU countries; in particular Australia and Canada?
 
Elsmar Forum Sponsor
C

Curtis317

#2
The CE mark states that the product meets all requirements. If one of the requirements is ROHS compliance then you must meet those requirements. Also I suspect but am not sure but both Canada and Australia will have their own ROHS type requirements. Also most customers that that requirement also so even if the country does not have that requirement you need to be compliant anyway
 
J

JackPack

#3
After RoHS Recast, RoHS 2 is currently a part of the CE Marking Directive. A non RoHS compliant product cannot be CE Marked. Doing so is a violation of the European law. However this is a European law. I am not sure what is the risk, or how likely it will be reported to the EU law enforcement by other countries. As of now, I don't think Canada or Australia has their own RoHS requirements. Also, like Curtis mentioned, customers have the power to make RoHS compliance as one of the product requirements. Hopefully you are able to assess the risks from the feedback.
 
Thread starter Similar threads Forum Replies Date
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
C Difficulties getting RoHS/REACH for cheap parts RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
R ROHS Exemption Declarations REACH and RoHS Conversations 5
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
padraick63 REACH and ROHS Requirement for a Molded Part REACH and RoHS Conversations 1
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
T China ROHS exemptions - Are there any exemptions for ROHS 2 China? REACH and RoHS Conversations 0
D The Status of ROHS for Medical Devices - April 2019 REACH and RoHS Conversations 3
Ed Panek CE REP questions about our devices ROHS compliance REACH and RoHS Conversations 1
R REACH and ROHS compliance for hundreds of parts made over 25 years REACH and RoHS Conversations 3
S Prop 65 and RoHS statement REACH and RoHS Conversations 6
J What my companies RoHS declaration should say 2011/65/EU, 2015/863, or 2017/2102 REACH and RoHS Conversations 3
bio_subbu EU Publishes New DIRECTIVE (EU) 2017/2102 AMENDING 2011/65/EU ON ROHS-2 REACH and RoHS Conversations 0
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
D How do I show compliance to RoHS, REACH and Conflict Minerals? REACH and RoHS Conversations 6
J RoHS, WEEE and REACH Consulting Expertise Needed REACH and RoHS Conversations 4
P Necessary Compliance Documentation for RoHS and REACH REACH and RoHS Conversations 5
Q Guidance regarding Legally Refurbishing a Non-RoHS Instrument in the EU REACH and RoHS Conversations 1
M ROHS & REACH in TEFLON Material - NABL Testing Laboratories REACH and RoHS Conversations 1
S Sell a Non-RoHS device, manufactured before RoHs regulations became effective? EU Medical Device Regulations 2
Q EU ROHS and GUI Usability Trial Requirements EU Medical Device Regulations 10
M RoHS Directive - Supplier Compliance - Declaration of Conformance CE Marking (Conformité Européene) / CB Scheme 12
dubrizo Who handles Your Reach, RoHS, 3TG Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 9
smryan Compliance Officer Outsourcing? RoHS, REACH, ELV, GADSL, IECSC Other ISO and International Standards and European Regulations 5
B RoHS Directive 2014/5/EU Leaded Solder Exemption RoHS, REACH, ELV, IMDS and Restricted Substances 2
bio_subbu Official Journal of EU published two new RoHS Exemptions EU Medical Device Regulations 1
A RoHS compliance - Our market is non EU countries only ISO 13485:2016 - Medical Device Quality Management Systems 4
D Will A Few Failed Solder Joints Make Me RoHS Non Compliant? RoHS, REACH, ELV, IMDS and Restricted Substances 9
L IOS-MAT-0010 vs REACH/ROHS RoHS, REACH, ELV, IMDS and Restricted Substances 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N RoHS Compliance requirement for Hexavalent Chromium RoHS, REACH, ELV, IMDS and Restricted Substances 6
R RoHS Compliance Problem with One Component RoHS, REACH, ELV, IMDS and Restricted Substances 5
J RoHS Components with Lead Exemptions (Capacitors on a PCB) RoHS, REACH, ELV, IMDS and Restricted Substances 11
B Query on Medical Device Electronics RoHS Certificate Statement RoHS, REACH, ELV, IMDS and Restricted Substances 3
R RoHS Medical Devices: Application to Accessories, Components and Non-EE parts CE Marking (Conformité Européene) / CB Scheme 10
M Finding a hardware supplier/distributor compliant with RoHS RoHS, REACH, ELV, IMDS and Restricted Substances 1
SteveK RoHS Conformity Risk Assessment - Medical Devices RoHS, REACH, ELV, IMDS and Restricted Substances 2
SteveK RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014 CE Marking (Conformité Européene) / CB Scheme 30
J RoHS-Non RoHS Multifunctional Workbench RoHS, REACH, ELV, IMDS and Restricted Substances 1
M RoHS CE Mark - Medical Devices built for US before 22 July 2014 ISO 13485:2016 - Medical Device Quality Management Systems 3
L What needs to be done to prove compliance with RoHS and WEEE EU Medical Device Regulations 5
A Start Compliance to RoHS, SCHV and REACH RoHS, REACH, ELV, IMDS and Restricted Substances 10
S What needs to be done to demonstrate RoHS compliance for Medical Devices? RoHS, REACH, ELV, IMDS and Restricted Substances 6
A ROHS and CE Mark - Requirements for a Class IIa Medical Device EU Medical Device Regulations 6
M RoHS for Disposable Medical Device Assemblies RoHS, REACH, ELV, IMDS and Restricted Substances 1
somashekar Where does RoHS stuff get audited by CB's? Quality Manager and Management Related Issues 3
somashekar Am I good to claim RoHS for my product? Solder Content RoHS, REACH, ELV, IMDS and Restricted Substances 8
R RoHS for Medical Devices - Does the directive apply to non-EEE accessories? RoHS, REACH, ELV, IMDS and Restricted Substances 1
Similar threads


















































Top Bottom