MDR and Accessories

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
The product in question consists of a wearable soft patch and a smart device app to display the data it transmits. The MDR defines an accessory as an article whilest not being part of a medical device is intended by its manufacturer to be used together with one or several particular medical devices to enable the device to meet its intended purpose.

Would all iPhones and Galaxy phones capable of running our Software be considered to be an accessory?

This would require us to have a design file for each model phone and each phone listed in our DoC?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Do you know how to find section G4 in the MDR and what is generic Device groups and how is it located? Also what does the term immediate danger in the context of MDR mean?
 
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dgrainger

Trusted Information Resource
HI,

Not sure what you mean by section G4.

MDR Article 2 (7)
"‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics "

MDCG 2019-13:
"3.2. Generic device group: is to be understood:
  • in respect of the MDR as the 4th level of the European Nomenclature on Medical Devices (EMDN) (i.e. combination of one letter plus 6 digits), and
  • in respect of the IVDR as the 3rd level of the EMDN (i.e. combination of one letter plus 4 digits respectively) in combination with the most appropriate IVP code."

I don't think that "immediate danger" has been defined in MDR/MDCG or previously in MDD/MEDDEV, you'll just have to go with a dictionary definition and look at the examples in classification guidance.
 

QuinnM

Involved In Discussions
Just thinking - Would you need to have a design file for each medical device, or operating system?
 
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