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.
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.