1. Software & Apps - to be a medical device or not
Introduction
Author - Arild R. Hansgård
Date - 18 November 2018 1

2. History
Different applications
Definitions
Key Words Guidance documents

3. History
1992
1993
1994
2006
2007
2009
2011
2017
MDD 93/42/EEC
Am. Directive 2007/47 / EC enter into force.
MDR enter into force
PACS deployed at Army Clinics in the USA.
DICOM-standard introduced
First smartphone on the market in the USA
Nokia
IPhone
First stand alone SW certified by Nemko
First mobile app certified by Nemko 3

4. Different applications
Fitness
- Rehabilitation purposes - Various aids for people with disabilities - Calculating medicine doses to take/inject - Diagnosis - Programs to support decision-making 4

5. Definitions Software:
“software” may be defined as a set of instructions that processes input data and creates output data.
Stand alone software:
‘stand alone software’ means software which is not incorporated in a medical device at the time of its placing on the market or its making available.
Software as a medical device:
Software intended to be used for one or more medical purposes
that perform these purposes without being part of a hardware medical device.
Definitions

6. Stand alone software is considered to be an active medical device.
Active therapeutical device:
Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or
restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.
Active device for diagnosis:
Any active medical device, whether used alone or in combination with other medical devices, to supply information for
detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
Definitions

7. Key Words Mode of action, Intended use and Medical Purpose
Software for general purposes when used in a healthcare setting is not a MD
Do the SW perform an action on data not limited to storage, archival, communication and simple search?
Is the action directly for the medical benefit of individual patients?
Do the description of purpose harmonize with the description of the purpose as given under the definition of medical devices, in the Directive. Medical Indications always have to be supported by adequate clinical data

8. Guidance documents MEDDEV 2.1/6
July MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY
REGULATORY FRAMEWORK FOR MEDICAL DEVICES
Version 1.17 ( )