Regulatory Open Forum

Hello Everyone!, 

I am working on obtaining UDI for a Medical device (System). The device is similar to an Cart Based Ultra-Sound System. 
Components of the System are
1. a Monitor,
2. cart,
3. A stylus for touch Monitor Touch Screen,
4. some power Cords and
5. 2 Probes (similar to Ultrasound probes, each probe has its own intended use.)
6. UPS Battery

Initially, the hospital would have to buy the entire system, however, if a component (Example - Monitor, stylus, power chord, Probe) needs replacement, they can be bought separately. 

Based on My understanding of the EU MDR 2017/745 UDI requirements is that, The UDI is needed for either only the system or for the System and the probes. 

I would like to seek guidance from the experts here, if my understanding is correct and if the best approach is to have 
1)  One UDI for System + Components
Or
2)   One UDI for System , One UDI for each of the probe?

Also I believe we need not have UDI on the other components such as Monitor, Stylus, UPS Battery and Chord,  is my understanding correct?

Your comments in this regards are highly appreciated. 


------------------------------
Vinoda Palanisamy
Senior Regulatory Affairs Specialist
Princeton NJ
United States
------------------------------

Hi, Vinoda
Please refer to: 200602_MTE-Basic-UDI-DI-guidance-v1.1_final.pdf (medtecheurope.org)

"If the device is a system of several components/devices, each device in the system should have a
Basic UDI-DI but also one Basic UDI-DI for the system."  (pg 11) 

Please also refer to: Systems and Procedure Packs: Regulatory Requirements (johner-institute.com)
As there need to be internal monitoring, verification and validation requirements for non-medical device component or component manufactured by other manufacturers. There might be obligations more than just a BUDI for the probes and monitors if necessary.



------------------------------
May Meng RAC, PhD
Oxford
United Kingdom
------------------------------

Original Message:
Sent: 30-Oct-2022 15:47
From: Vinoda Palanisamy
Subject: UDI - Components

Hello Everyone!,

I am working on obtaining UDI for a Medical device (System). The device is similar to an Cart Based Ultra-Sound System.
Components of the System are
1. a Monitor,
2. cart,
3. A stylus for touch Monitor Touch Screen,
4. some power Cords and
5. 2 Probes (similar to Ultrasound probes, each probe has its own intended use.)
6. UPS Battery

Initially, the hospital would have to buy the entire system, however, if a component (Example - Monitor, stylus, power chord, Probe) needs replacement, they can be bought separately.

Based on My understanding of the EU MDR 2017/745 UDI requirements is that, The UDI is needed for either only the system or for the System and the probes.

I would like to seek guidance from the experts here, if my understanding is correct and if the best approach is to have
1)  One UDI for System + Components
Or
2)   One UDI for System , One UDI for each of the probe?

Also I believe we need not have UDI on the other components such as Monitor, Stylus, UPS Battery and Chord,  is my understanding correct?

Your comments in this regards are highly appreciated.


------------------------------
Vinoda Palanisamy
Senior Regulatory Affairs Specialist
Princeton NJ
United States
------------------------------

Thank you May, 


------------------------------
Vinoda Palanisamy
Senior Regulatory Affairs Specialist
Dallas TX
United States
------------------------------

Original Message:
Sent: 30-Oct-2022 18:14
From: May Meng
Subject: UDI - Components

Hi, Vinoda
Please refer to: 200602_MTE-Basic-UDI-DI-guidance-v1.1_final.pdf (medtecheurope.org)

"If the device is a system of several components/devices, each device in the system should have a
Basic UDI-DI but also one Basic UDI-DI for the system."  (pg 11)

Please also refer to: Systems and Procedure Packs: Regulatory Requirements (johner-institute.com)
As there need to be internal monitoring, verification and validation requirements for non-medical device component or component manufactured by other manufacturers. There might be obligations more than just a BUDI for the probes and monitors if necessary.



------------------------------
May Meng RAC, PhD
Oxford
United Kingdom

Original Message:
Sent: 30-Oct-2022 15:47
From: Vinoda Palanisamy
Subject: UDI - Components

Hello Everyone!,

I am working on obtaining UDI for a Medical device (System). The device is similar to an Cart Based Ultra-Sound System.
Components of the System are
1. a Monitor,
2. cart,
3. A stylus for touch Monitor Touch Screen,
4. some power Cords and
5. 2 Probes (similar to Ultrasound probes, each probe has its own intended use.)
6. UPS Battery

Initially, the hospital would have to buy the entire system, however, if a component (Example - Monitor, stylus, power chord, Probe) needs replacement, they can be bought separately.

Based on My understanding of the EU MDR 2017/745 UDI requirements is that, The UDI is needed for either only the system or for the System and the probes.

I would like to seek guidance from the experts here, if my understanding is correct and if the best approach is to have
1)  One UDI for System + Components
Or
2)   One UDI for System , One UDI for each of the probe?

Also I believe we need not have UDI on the other components such as Monitor, Stylus, UPS Battery and Chord,  is my understanding correct?

Your comments in this regards are highly appreciated.


------------------------------
Vinoda Palanisamy
Senior Regulatory Affairs Specialist
Princeton NJ
United States
------------------------------