Regulatory Open Forum

Hello,

I wanted to gain some insight into the EU MDR Patient Implant Card requirement for Implantable Accessories. The accessories are implanted in the brain along with the main device. Do we need to have a PIC card for accessories such as connectors, clips, fixation tabs, and tubing plugs?

Thanks!

Hi Shikha,

the MDR Article 18 refers to "implanted devices", which would mean the requirements also apply to any accessory (in the sense of Article 2(2)). However, Article 18(3) makes exceptions for "sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors." and opens up the possiblity to the EU to add to that list (which is currently not the case).

So in your case the connectors and clips are directly mentioned under the exceptions and you might be able to assign the fixation tabs and tubing plugs to one of the other exceptions.

In addition, MDCG 2019-8 contains some thoughts on a "system implant card", a concept that is not directly covered by the MDR. As far as I can see this would apply to systems in the sense of Article 22(1). For a system that is a device in its own right (Article 22(4)) I assume that a single implant card might be sufficient (as the system as a whole is considered the device).

Best regards

Christoph

Hello,

I wanted to gain some insight into the EU MDR Patient Implant Card requirement for Implantable Accessories. The accessories are implanted in the brain along with the main device. Do we need to have a PIC card for accessories such as connectors, clips, fixation tabs, and tubing plugs?

Thanks!

Please ALWAYS consider to include MR Conditional labeling information on the implant card.

See ASTM F2503 and the FDA guidance on the topic (Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment).

Hi Shikha,

the MDR Article 18 refers to "implanted devices", which would mean the requirements also apply to any accessory (in the sense of Article 2(2)). However, Article 18(3) makes exceptions for "sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors." and opens up the possiblity to the EU to add to that list (which is currently not the case).

So in your case the connectors and clips are directly mentioned under the exceptions and you might be able to assign the fixation tabs and tubing plugs to one of the other exceptions.

In addition, MDCG 2019-8 contains some thoughts on a "system implant card", a concept that is not directly covered by the MDR. As far as I can see this would apply to systems in the sense of Article 22(1). For a system that is a device in its own right (Article 22(4)) I assume that a single implant card might be sufficient (as the system as a whole is considered the device).

Best regards

Christoph

Hello,

I wanted to gain some insight into the EU MDR Patient Implant Card requirement for Implantable Accessories. The accessories are implanted in the brain along with the main device. Do we need to have a PIC card for accessories such as connectors, clips, fixation tabs, and tubing plugs?

Thanks!

Please ALWAYS consider to include MR Conditional labeling information on the implant card.

See ASTM F2503 and the FDA guidance on the topic (Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment).

Hi Shikha,

the MDR Article 18 refers to "implanted devices", which would mean the requirements also apply to any accessory (in the sense of Article 2(2)). However, Article 18(3) makes exceptions for "sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors." and opens up the possiblity to the EU to add to that list (which is currently not the case).

So in your case the connectors and clips are directly mentioned under the exceptions and you might be able to assign the fixation tabs and tubing plugs to one of the other exceptions.

In addition, MDCG 2019-8 contains some thoughts on a "system implant card", a concept that is not directly covered by the MDR. As far as I can see this would apply to systems in the sense of Article 22(1). For a system that is a device in its own right (Article 22(4)) I assume that a single implant card might be sufficient (as the system as a whole is considered the device).

Best regards

Christoph

Hello,

I wanted to gain some insight into the EU MDR Patient Implant Card requirement for Implantable Accessories. The accessories are implanted in the brain along with the main device. Do we need to have a PIC card for accessories such as connectors, clips, fixation tabs, and tubing plugs?

Thanks!