Regulatory Open Forum

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

With no specific requirements, think about how the implant card is used.

I have four, issued in the US, and I carry them in my wallet. The requirement is that they fit in a wallet (credit card size) and that they are durable. For examples, think of other things that have similar requirements such as a Social Security card, a Covid vaccination card, and a business card.

If you print them on heavy business card stock, you should be good to go.

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

With no specific requirements, think about how the implant card is used.

I have four, issued in the US, and I carry them in my wallet. The requirement is that they fit in a wallet (credit card size) and that they are durable. For examples, think of other things that have similar requirements such as a Social Security card, a Covid vaccination card, and a business card.

If you print them on heavy business card stock, you should be good to go.

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

With no specific requirements, think about how the implant card is used.

I have four, issued in the US, and I carry them in my wallet. The requirement is that they fit in a wallet (credit card size) and that they are durable. For examples, think of other things that have similar requirements such as a Social Security card, a Covid vaccination card, and a business card.

If you print them on heavy business card stock, you should be good to go.

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

------------------------------
Thomas Saladin
Regulatory Affairs Specialist
Minnetonka MN
United States
------------------------------

Hello Thomas,

I hope you are well. 

Per my knowledge, there is know specified requirement regarding the thickness of the patient implant cards. We made an implant card using a Card stock and dimensions as specified in the MDCG guidance. The general idea is to have the required information about the implant clear, concise and legible for patients. 

I hope this helps!

Nivi

------------------------------
Nivedita Namjoshi
Massachusetts

Original Message:
Sent: 05-Sep-2023 12:21
From: Thomas Saladin
Subject: Question about EU Implant Cards/Informative Leaflets

Hi all,

I have a question regarding patient implant cards (required under certain circumstances per MDR Article 18) and their accompanying informative instruction leaflets, as described in guidance MDCG 2019-8 v2. This guidance notes that the outer dimensions of the implant card should be the same as those of a credit card, i.e. 85.60 mm x 53.98 mm.

However, I do not see that there is any stated requirement on how thick the implant card should be (e.g., whether it can be as thin as paper or must be as thick as a credit card), or any requirement on the material the card should be constructed with. I also do not see any requirements on dimensions or materials for the informative instructional leaflet.

I would expect that if there were any requirements, they would be listed in MDCG 2018-9. Is anyone aware of any such requirements for the EU/MDR that are stated elsewhere?

Thanks!

------------------------------
Thomas Saladin
Regulatory Affairs Specialist
Minnetonka MN
United States
------------------------------