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Accessory or I-don't-know-what-to-call-it-at-this-point

MDD_QNA

Involved In Discussions
#1
We are working on a device/component or I-don't-know-what-to-call-it-at-this-point, to our main device. However, with all the possibilities/limitations that is ahead of us we are discussing whether or not it should be classified as an accessory or as a stand alone device (then it will be a class I MD) or a software w no medical purpose (which it is already).
Considering MDR, and the fact that we want to be able to sell the device as a stand alone device, is that feasible if it is classified as an accessory? I want to classify it as an accessory since I believe it is the easiest route. Can you direct me to any documents or information with regards to accessory? The only thing I can find is in the directive and in one meddev guidance.
Thanks!
 
#2
Have a look at Article 2:
Definitions:
(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);​

And Annex II 1.1
The technical documentation for your main device must contain "(h) a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;"​

It can only be a device if it has its own medical purpose.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
We are working on a device/component or I-don't-know-what-to-call-it-at-this-point, to our main device. However, with all the possibilities/limitations that is ahead of us we are discussing whether or not it should be classified as an accessory or as a stand alone device (then it will be a class I MD) or a software w no medical purpose (which it is already).
Considering MDR, and the fact that we want to be able to sell the device as a stand alone device, is that feasible if it is classified as an accessory? I want to classify it as an accessory since I believe it is the easiest route. Can you direct me to any documents or information with regards to accessory? The only thing I can find is in the directive and in one meddev guidance.
Thanks!
1. The MDD and MEDDEVs will soon be officially irrelevant to new devices, definitely to plain class 1.
2. Other than general advice (like @dgrainger provided) it's impossible to address your question, knowing practically nothing on how that SW is supposed to be used, what for, with what other objects etc.
 

MDD_QNA

Involved In Discussions
#4
The software is supposed to be used with a patient positioning system and the software is intended to store data on how the patient is positioned and how to get the patient in the right position during the whole treatment.
 
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