1. February 2014
mobile Health
International regulatory perspectives
Koen Cobbaert – IT Regulatory Manager

2. software-only products*
can be
a medical device
(if they meet the definition)
*including mobile apps

3. 3
Regulators register software-only products
as medical devices

4. 4
Legislative texts and guidance on medical software
including mobile apps

5. 5

6. 6

7. 7

8. 8

9. 9

11. page 11 of total
regulators draw new lines in the sand

15. 15
the future
a global legislative jungle?

16. 16

17. 17
simplicity
the most difficult thing of all

18. IMDRF: another road

19. IMDRF: risk types

20. less regulatory burden
without loss of regulatory oversight
IMDRF: regulatory controls

21. the end