MDR Technical File for more than 1 medical device

[sophgira]

Hi, we have a main medical device that is Class IIb and intended to physically eliminate bacteria on wounds. This medical device needs to be used with a sensor module (also a medical device, Class I) attached to the torch head, for safety reasons.

We have the main medical device and the sensor module in the same technical file and I was wondering if this could be seen as a family?
Can we say the sensor module is an accessory although it's a medical device itself? Both can't be used alone.

We have an upcoming MDR and ISO13485 audit and I am concerned they could pick up on this.

Thanks a lot!!

 

[Al_Z1]

Hi.I guess, in sense of IEC 60601-1 it could be an ME system, according to the definitions of it. If there is energy or information exchange between your main and additional modules they could be defined as system, depending, of course, on intended use.
As for family - it is used for several similar devices, which have some technical parameters quantatively different between one another, for example, power or output voltage etc.
HTH

 

[EmiliaBedelia]

There's no restriction on how many devices you can have in a technical document, but your notified body may want you to split up classifications/technical features simply from an organizational perspective. IME my NB did not let us put Class IIa and Class I devices in the same file because it messes up their sampling plans and review process. If you define the head as an accessory to the main device you might be able to get around this, but I think it would depend on how different the technological characteristics are between the head and the main device.

Under MDR, accessories are treated as devices and are subject to the same regulations. You could identify the head as an accessory within the technical document, but you need to ensure that it meets the regulatory requirements as its own device. You need to classify the sensor head in its own right in accordance with the classification rules. For example, if the head is sterile and disposable and patient contacting and the body is reusable, non-sterile, and active, these are different characteristics and they should be assessed differently. "Family" isn't really a term under MDR so I wouldn't use that terminology - I'd focus on the "accessory" definition.

 

[sophgira]

There's no restriction on how many devices you can have in a technical document, but your notified body may want you to split up classifications/technical features simply from an organizational perspective. IME my NB did not let us put Class IIa and Class I devices in the same file because it messes up their sampling plans and review process. If you define the head as an accessory to the main device you might be able to get around this, but I think it would depend on how different the technological characteristics are between the head and the main device.

Under MDR, accessories are treated as devices and are subject to the same regulations. You could identify the head as an accessory within the technical document, but you need to ensure that it meets the regulatory requirements as its own device. You need to classify the sensor head in its own right in accordance with the classification rules. For example, if the head is sterile and disposable and patient contacting and the body is reusable, non-sterile, and active, these are different characteristics and they should be assessed differently. "Family" isn't really a term under MDR so I wouldn't use that terminology - I'd focus on the "accessory" definition.

Thank you that helps a lot!