Discussion about Accessory definition in the proposal of new EU regulation

c.mitch

Quite Involved in Discussions
#1
Hi folks,

I'd like to know if you wonder what's behind this definition in the Article 2.1 of the proposal of new regulation:
An accessory is an article which whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s)

In the current 93/42 directive modified 2007/47, the word assist is not present in the definition of an accessory.

The word "enable" is simple to understand i.e. if the article is not present, the device can't be used. Thus the article is an accessory to the device.
The word "assist" is more ambiguous i.e. if the article is not present, the device may still be used.

Would you think, like me, that some articles that were not accessories fall into the scope of accessories according to the new definition?

Example (from a real case):
A dynamic presentation of a surgical technique that is displayed in the OR to assist the surgeon in the use of surgical instruments could fall in the scope of the new directive. While today it doesn't.
 
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MIREGMGR

#2
I think I understand the thrust of the change: the prior language was interpreted as you state, i.e. if the article was not present, the device could not be used. But this did not account for articles that, while not essential to the use of the device, nonetheless were helpful or even critically important in using the device with optimal safety and effectiveness. The new language allows this kind of important-even-if-not-essential functionality/usability improvement to be within the accessory definition.

As you note, though, the potential scope of the revised wording is extremely broad. I don't know how it will be limited in practice, except perhaps by someone writing a guidance.
 

c.mitch

Quite Involved in Discussions
#3
Yes, I agree with you. Fortunately, this is still a proposal. That's not a secret that lobbies in action in Brussels are excepted to make dramatic changes to the whole text.
 
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