February 2014

mobile Health International regulatory perspectives Koen Cobbaert – IT Regulatory Manager

software-only products*

can be

a medical device

(if they meet the definition)

*including mobile apps

3

Regulators register software-only products as medical devices

4

Legislative texts and guidance on medical software including mobile apps

5

6

7

8

9

page 11 of total regulators draw new lines in the sand

15

the future a global legislative jungle?

16

17

simplicity the most difficult thing of all

IMDRF: another road

IMDRF: risk types

less regulatory burden without loss of regulatory oversight

IMDRF: regulatory controls

the end