EU Classification Flashcards
1
Q
Which is the new version of ISO13485 to be updated by deadline of March 2019?
A
ISO 13485:2016 (E)
2
Q
As per which annex, EU MDR classifies medical devices taking into account their intended purpose and inherent risks?
A
Annex VIII (22 classification rules)
3
Q
What can be the example of a device approved by competent national authorities within its territory based on a compassionate grounds for a real clinical need?
A
Orphan devices
4
Q
In which class surgically invasive devices intended for transient use categorized?
A
Class IIa
5
Q
What a stand-alone software is considered as?
A
Active medical device
