RoHS Conformity Risk Assessment - Medical Devices

SteveK

Trusted Information Resource
#1
What would a RoHS conformity risk assessment look like for medical devices?

Is one really required?

If so has anyone got a (generic) example to share?

Steve
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#3
Not sure why a separate risk assessment would be required...
Not even sure I know what you mean... Are you referring to a risk assessment of NOT complying (probably not recommended), or a residual risk assessment of trace hazardous substances that may still be present even though RoHS directive has been met?

I think probably line items in whatever risk assessment you have dealing with materials is probably sufficient:
- Hazard: poisoning by hazardous substances in materials, environmental contamination
- Risk: (evaluated)
- Mitigation: RoHS compliance SOP, materials testing..etc.
- Verification: Materials data, test-reports etc.
 
Thread starter Similar threads Forum Replies Date
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
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
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
R RoHS and placing on the market in Non EU countries RoHS, REACH, ELV, IMDS and Restricted Substances 3
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

Similar threads

Top Bottom