MDR CMR substances

[Malomsoki Gabor]

Hi all,
We supply metal parts for surgical instruments, but we are not the medical device manufacturer or the legal manufacturer.
A customer is requesting a confirmation regarding CMR substances (category 1A/1B) under MDR (EU 2017/745).
What is the best way for a supplier like me to provide this safely?
Do you typically rely on supplier declarations, material certifications, or a specific wording to satisfy the customer without assuming MDR manufacturer responsibilities?
Thanks in advance for your guidance!

 

[Pavol M]

Responsibility for medical device has only manufacturer, not supplier. I think that if you provide them material certificate, with material composition and properties (i think that it will be for stainless steel), it will be sufficient.

 

[Nichole F]

The responsibility for determining CMR presence, concentration, etc. belongs with the manufacturer. CMR substances are to be declared in the IFU per MDR 2017/745 Annex I 23.4(s). As the supplier, you should probably reach out to the manufacturer or have your customer do so. They may provide a material certificate stating no CMRs or an attestation claiming compliance with CMR requirements under EU 2017/745. Without involving the manufacturer, the only thing you can probably safely say is the device claims compliance with EU 2017/745 which requires CMRs to be declared in the IFU.

 

[EmiliaBedelia]

The responsibility for determining CMR presence, concentration, etc. belongs with the manufacturer. CMR substances are to be declared in the IFU per MDR 2017/745 Annex I 23.4(s). As the supplier, you should probably reach out to the manufacturer or have your customer do so. They may provide a material certificate stating no CMRs or an attestation claiming compliance with CMR requirements under EU 2017/745. Without involving the manufacturer, the only thing you can probably safely say is the device claims compliance with EU 2017/745 which requires CMRs to be declared in the IFU.

It sounds like OP is a subcomponent supplier? The customer may in fact be a medical device manufacturer who is looking for information to complete their own responsibility re: CMR.

The IFU alone isn't the only manufacturer responsibility for CMR/endocrine disrupting substances so I wouldn't make a declaration based on that alone... The manufacturer needs to determine the applicability of section 10.4.1 in the first place (based on intended use), calculate the w/w% concentration of the CMR substance in the finished device as well as complete a risk/benefit analysis. I would also argue that the manufacturer is the one responsible for identifying CMR/endocrine disrupting substances per the EU hazardous substance lists in the first place. They should have some kind of "monitoring" process to keep track of updates to those lists.

As a subcomponent supplier, I would say OP should provide the material specifications for the components they supply with exact % elemental composition and "unknown"/"impurities" % and potentially the component weight if they are feeling generous. The manufacturer should be responsible for checking those elements against the hazardous substance lists and determining the TOTAL device w/w% to decide if they need to label/assess CMR risk at all. Nothing that you provide here is going to make you an LM per MDR so you should be in the clear in that respect.

 

[Nichole F]

It sounds like OP is a subcomponent supplier? The customer may in fact be a medical device manufacturer who is looking for information to complete their own responsibility re: CMR.

The IFU alone isn't the only manufacturer responsibility for CMR/endocrine disrupting substances so I wouldn't make a declaration based on that alone... The manufacturer needs to determine the applicability of section 10.4.1 in the first place (based on intended use), calculate the w/w% concentration of the CMR substance in the finished device as well as complete a risk/benefit analysis. I would also argue that the manufacturer is the one responsible for identifying CMR/endocrine disrupting substances per the EU hazardous substance lists in the first place. They should have some kind of "monitoring" process to keep track of updates to those lists.

As a subcomponent supplier, I would say OP should provide the material specifications for the components they supply with exact % elemental composition and "unknown"/"impurities" % and potentially the component weight if they are feeling generous. The manufacturer should be responsible for checking those elements against the hazardous substance lists and determining the TOTAL device w/w% to decide if they need to label/assess CMR risk at all. Nothing that you provide here is going to make you an LM per MDR so you should be in the clear in that respect.

Ah. Yes, I think I misinterpreted OP's role as furthering the distribution of a finished medical device. As a component supplier, the material specifications for the components would be the best thing to supply.

I did not intend to imply the only manufacturer responsibility for CMR is in the IFU, only that the IFU would be the place CMR declaration is visible to the customer.