Clarification on MDR - Article 18(d) - Implant Card

Marcelo

Inactive Registered Visitor
#11
The materials used (raw materials) may not be the same, or only ones, in the final medical device, because this depends on the manufacturing process (including interaction with additives and processing aids, between other influences). That's why a materials characterization (of the final medical device) is a requirement for biological evaluation.
 
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moounir

Involved In Discussions
#12
The materials used (raw materials) may not be the same, or only ones, in the final medical device, because this depends on the manufacturing process (including interaction with additives and processing aids, between other influences). That's why a materials characterization (of the final medical device) is a requirement for biological evaluation.
Hi Marcelo,

When you say Material Characterization, can you be more precise on how this should be displayed? Is this a material linked to a standard or specific characteristic to mention. (Stainless Steel XC01H... - ISO XXXXX) or ...?

I am really interested as I want to see if I can create a template to help the community.

Thanks for your support.

Regards.
 

Thulasidharan

Starting to get Involved
#13
Good case. Thanks for this question. This will inspire me for my next article (y)

In my opinion, you should be consistent with the other documents. As the Implant Card is now part of the labeling material, you have to provide the same information as what is written on the Instruction for Use or the Label.

The implant card is specifically for the patient, not the doctors who already have the other documents (IFU and Label). With this new document, all the stakeholders have the same level of information.

I hope this helps.
Thank you for the quick help.
 

Marcelo

Inactive Registered Visitor
#14
Hi Marcelo,

When you say Material Characterization, can you be more precise on how this should be displayed? Is this a material linked to a standard or specific characteristic to mention. (Stainless Steel XC01H... - ISO XXXXX) or ...?

I am really interested as I want to see if I can create a template to help the community.

Thanks for your support.

Regards.
I'm talking about material characterization based on ISO 10993-18:2005 - Biological evaluation of medical devices -- Part 18: Chemical characterization of materials and ISO/TS 10993-19:2006 - Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials.
 
L

llz123

#15
Hi,
Can anyone clarify:
a. article 18 require implant card for implantable device.
b. article 2 explain the definition of implntable device as any device introduced by clinical intervention (MDD had surgical intervention.) at least for 30 days.
We manufacture urological Foley catheter that indicated for continues use at least for 30 days. Based on the definition above they are considered to be implantable device and will requre an implant card, which is rediculouse. Australia issued a guidance where they clearly clarified that implant card is required for permanent implantable device or for active implantable device. Can anyone clarify what about European countries?
 
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