EU Classification

Question 1

Which is the new version of ISO13485 to be updated by deadline of March 2019?

Answer 1

ISO 13485:2016 (E)

Question 2

As per which annex, EU MDR classifies medical devices taking into account their intended purpose and inherent risks?

Answer 2

Annex VIII (22 classification rules)

Question 3

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?

Answer 3

Orphan devices

Question 4

In which class surgically invasive devices intended for transient use categorized?

Answer 4

Class IIa

Question 5

What a stand-alone software is considered as?

Answer 5

Active medical device