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

[Thulasidharan]

Hi All,
Need Clarification on MDR - Article 18(d)
(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
(u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;

what the exact thing have to be presented?..

 

[Marc]

A quick "Bump" - My Thanks in advance to anyone who can help with this one.

 

[Marcelo]

Not sure about the questions, the examples seem to be quite clear (d links to a specific section, and U clearly tells what is the information).

 

[Thulasidharan]

Not sure about the questions, the examples seem to be quite clear (d links to a specific section, and U clearly tells what is the information).

If possible can you guide me how can able to arrive the qualitative & quantitative information in materials?

 

[Marcelo]

If possible can you guide me how can able to arrive the qualitative & quantitative information in materials?

Material characterization. This is a required part of the biological evaluation following the ISO 10993 series.

 

[Thulasidharan]

Material characterization. This is a required part of the biological evaluation following the ISO 10993 series.

thanks for the guidance

 

[moounir]

Hi Thulasidharan,

I think on this specific one, its to define the material used. If it's a system of screws, you'll need to indicate which alloy is used. Stainless steel (ISO reference maybe) or Titanium TA6V or PEEK or Silicon gel (Ref...).

It would help in case the material used is not compatible with some other equipment like MRI or if there is are some contra-indication to use some other devices or medicines due to that. Or in case of pathology.

I remember that I received once a call from a UK hospital because one of there patient had our implants on the body. They needed to perform some exams and they wanted to confirm the material used for that implant to not hurt the patient.

I don't think we are obliged to write on the implant card if the implant is not compatible with different types of equipment but it would be useful for the patient and its doctor.

I hope this helps.

 

[Thulasidharan]

Hi Thulasidharan,

I think on this specific one, its to define the material used. If it's a system of screws, you'll need to indicate which alloy is used. Stainless steel (ISO reference maybe) or Titanium TA6V or PEEK or Silicon gel (Ref...).

It would help in case the material used is not compatible with some other equipment like MRI or if there is are some contra-indication to use some other devices or medicines due to that. Or in case of pathology.

I remember that I received once a call from a UK hospital because one of there patient had our implants on the body. They needed to perform some exams and they wanted to confirm the material used for that implant to not hurt the patient.

I don't think we are obliged to write on the implant card if the implant is not compatible with different types of equipment but it would be useful for the patient and its doctor.

I hope this helps.

 

[Thulasidharan]

Thanks for the guidance.
But in our case we are the manufacturers of urological devices like urethral catheter, urethral stent... in this case more than one material used for making the device and implant part also contains many combinations of the materials. So we have to analyze which material can expose the patient then we have to give the relevant details ... am i right? if not please correct me .....

 

[moounir]

Good case. Thanks for this question. This will inspire me for my next article

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.