Interpretation of the MDR GSPR 23.4 (u)

image182

Involved In Discussions
#1
Hi all

I'm wrestling with the interpretation of the MDR GSPR 23.4 (u) where a requirement in the IFU is that "in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;"

Obviously manufacturers will not want to release the quantitative formulation of your device into the public domain when you're attempting to complete against other companies.

Additionally I noted that, it's completely plausible that when attempting to be in compliance with the labelling requirements under GSPR 23.4(u) and GSPR 10.4.5 the reach different conclusions and end up contradicting each other.

Whereas when GSPR 10.4 provides a clear understanding on what the context for identifying chemicals on the labelling are... I've not seen any clarification or guidance on how to interpret GSPR 23.4 (u) which is only a single sentence.

Has anybody seen any guidance or anything which would help with the correct interpretation of GSPR 23.4(u)? Or perhaps someone has started discussions with their notified body already on this point and could offer some insight into how the notified bodies are interpreting this?

Any feedback or thoughts would be welcome!
 
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dgrainger

Trusted Information Resource
#2
Manufacturers many not want to but they have to include the information in the IFU - it's not optional - Also required in the Patient information requirements of Article 18(d).
 

monoj mon

Involved In Discussions
#3
Obviously manufacturers will not want to release the quantitative formulation of your device into the public domain when you're attempting to complete against other companies.
To my understanding, this requirement is asking the manufacturer to provide the final (overall) composition which the patient may be exposed to during implantation. For example, if your product is a copolymer, you are supposed to give the information on the final material(s) but not the individual monomer constituents. If it has a degradation profile, you may qualitatively/quantitatively identify it along with what is degraded and how it will be released from the body.
 
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