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EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content

#1
Hi all,

I was hoping to get some guidance regarding the labelling requirements for devices/ articles which contain CMRs or substances with endocrine-disrupting (ED) properties. I understand that where there is a concentration above 0.1% w/w, a reference to these substances must be made on the labeling and IFU. There is however an additional requirement surrounding vulnerable patients (see text in red below).

Annex I - Chapter I, Section 10.4.5.
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.

Does anyone know whether the additional information for vulnerable patients is required for devices containing ANY amount of CMRs or substances with ED or is it only needed when above the 0.1% w/w threshold.

Any guidance would be very appreciated :agree1:
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
Laduncan,

the substance requirements and restrictions in Annex I, section 10.4 apply when the 0.1% w/w threshold is exceeded.

HTH,

Gerhard
 
#3
Hi Gerhard,

thank you for your response. That was my interpretation also!

I was wondering if you know of any reference material I could use to show my colleagues who are a little unsure.

All the best

Duncan
 

planB

Trusted Information Resource
#4
Duncan,

are you a member of Medtech Europe? This industrry organisation provides a guidance document called "MDR requirements on hazardous substances". As both manufacturers and notified bodies (to my knowledge no notifed body is accredited under the MDR as of today, thus not a single medical device is CE marked under the MDR either) have no previous experience with interpreting the MDR, in my view the dust has not settled on interpreting the requirements of the MDR. However, for the substance threshold the MDR is in my view pretty clear; it is also substantiated by the fact that this same threshold can found in other chemicals-related regulations like RoHS, REACh or CLP, that the MDR is referring to.

HTH,

Gerhard
 

Ellison

Starting to get Involved
#5
Hi,
Where you able to find the document referenced above? I have scoured the medtech site but have not been able to find it.

Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#6
In terms of the English language, how otherwise would you interpret the word "such" in "If the intended use of such devices..."?
 
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