HANDIHealth is developing apps to transform healthcare using an app-based model. The presentation discusses how the European Medical Device Directive (MDD) may apply to medical apps. It notes that apps influencing clinical decisions or therapy should be considered medical devices. Key requirements for medical devices include clinical safety risk analysis, quality management systems, and post-market surveillance. The intended use and ability to analyze data to generate new information help determine if software meets the definition of a medical device. Manufacturers of apps deemed medical devices must comply with the MDD.

1. Apps to Transform Health and Care – That’s
HANDI
www.handihealth.org
HANDIHealth Community Interest Company

2. Why HANDI?

Because we believe apps and the app
paradigm can transform health and care

3. Dr Neill Jones

General Practitioner

Clinical Informatician

Ex Clinical Director FDBE
− took product through the MDD

4. Medical device directive and the implications for
Medical APPS

Outline of the Presentation

Medical Device Directive

Clinical Safety

Quality management systems

What is a medical device

What you need to do

Definitions and concepts

5. Medical Devices Directive 93/42/EEC

Requires manufacturers placing medical
device(s) on the Community market

Provide certain information to a Competent
Authority in a Member State where they
have a registered place of business.

6. Medical Device:
any instrument, apparatus, appliance,
software, material or other article, whether
used alone or in combination, including the
software intended by its manufacturer to be
used specifically for diagnostic and/or
therapeutic purposes and necessary for its
proper application, intended by the
manufacturer to be used for human beings
for the purpose of:

7. Purpose of:

diagnosis, prevention, monitoring,
treatment or alleviation of disease,

diagnosis, monitoring, treatment,
alleviation of or compensation for an injury
or handicap,

investigation, replacement or modification
of the anatomy or of a physiological
process,

8. control of conception
which does not achieve its principal intended
action in or on the human body by
pharmacological, immunological or
metabolic means, but which may be
assisted in its function by such means;
Dose the POPE know he should register the
rythm method as a medical device

10. DSCN 14/2009
Application of Patient Safety Risk
Management to the Manufacture of Health
Software

11. ISB 0129

Health Informatics — Application of clinical
risk management to the manufacture of
health software
(formerly ISO/TS 29321:2008(E))

DSCN14/2009

DSCN18/2009

12. Safety Risk analysis

If the manufacturer can provide information
showing that a safe design has been
established for a number of years and that
the product has been performing as
intended during that time such information
is likely to be sufficient to cover this
requirement

13. Modules
Some stand alone software may break down
into a significant number of applications for
the user where each of these applications
is correlated with a module.
Some of these modules may have a medical
purpose.
This raises the issue as to whether the whole product can be CE marked when not all applications have a medical purpose
It is the obligation of the manufacturer to identify the boundaries and the interfaces of the different modules/applications.
SOS intended for use in combination with other modules of the whole software structure, other devices or equipment, the whole
combination, including the connection system, must be safe and must not impair the specified performances of the modules
which are subject to the medical device Directives.

14. POST MARKET SURVEILLANCE

The Directive seeks to improve the protection of health and
safety of patients, by reducing the likelihood of similar
incidents being repeated. Consequently, the Regulations
require the manufacturer to immediately notify the Competent
Authority if the product has been involved in an incident:

Led to a death;

A serious injury or serious deterioration in the state of health

That might have led to death, serious injury

15. DECLARATION OF CONFORMITY
EC DECLARATION OF CONFORMITY
(Full quality assurance system)
The manufacturer must ensure application of
the quality system approved for the design,
manufacture and final inspection of the
products concerned, as specified in Section
3 and is subject to audit as laid down in
Sections 3.3 and 4 and to Community
surveillance as specified in Section 5.

16. What is a medical device

Any complex algorithm upon which a
clinician may rely on where the calculation
is not apparent to the clinician.

The software used for the Pandemic flu
line has been classified as a medical
device because it lead to patients receiving
(or not) a medication.

CVS risk scope is almost certainly the
same category.

17. Decision Support Software
Computer based tools which combines
medical knowledge databases and
algorithms with patient specific data.
They are intended to provide healthcare
professionals and/or users with
recommendations for or information on
diagnosis, prognosis, monitoring and
treatment of individual patients.

18. 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.

19. Drug dosing systems
To calculate the drug dosage to be
administered to a specific patient and
therefore are qualified as medical devices.
This would include drug doses filter by age
sex gender indication.

20. Expert function software:
software which is able to analyse existing
information to generate new specific
information according to the intended use
of the software.

21. Intended purpose:
the use for which the device is intended
according to the data supplied by the
manufacturer on the labelling, in the
instructions and/or in promotional materials.

22. Placing on the market:
the first making available in return for
payment or free of charge of a device
other than a device intended for clinical
investigation, with a view to distribution
and/or use on the Community market,
regardless of whether it is new or fully
refurbished.

23. Summary

If an APP influences a Clinician and
probably also a Patient that results in
subsequent therapy you should seriously
consider if it is covered by the MDD and
seek expert guidance

Clinical safety and quality management
systems together with post marketing
survelance are critical to the process.

24. Questions

Neill.jones@nhs.net

MDD At MHRA

Full Directive

25. www.handihealth.org
info@handihealth.org
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