EU MDR GSPR 10.4.3 and 10.4.4

#1
Hi,

What are we supposed to list against GSPR 10.4.3 and 10.4.4 on the GSPR checklist? Can I just say "not applicable" as these are instructions to the Commission?

Thanks in advance.
Justin
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Justin,

"n/a" is only appropriate if your device (component) does not contain phthalates or CMR/ED substances in a concentration that is below 0.1 % weight by weight.

HTH,
 

shimonv

Trusted Information Resource
#3
This is from a publication by BSI on GSPR:
"SPRs 10.4.3 and 10.4.4 state that the European Commission shall provide the scientific committee provided for in the Regulation with a mandate to prepare guidelines including a risk-benefit assessment of phthalates as well as other CMR and endocrine-disrupting substances. Phthalates are currently addressed in MDD ER 7.5 and not specifically
addressed in the AIMDD. There is no immediate action required for manufacturers at present; however, manufacturers of devices including phthalates, CMR substances, or endocrine-disrupting substances must keep these forthcoming guideline reports in mind and account for this in plans to meet the MDR requirements. Manufacturers may reference as examples similar opinion reports from the scientific committee on emerging and newly identified health risks"

I agree with PlanB. If it is applicable, just state what you do have.

Shimon
 
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