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Medical Device
Directive
Dr Neill Jones
General Practitioner
Clinical Informatician
Ex Clinical Director FDBE
www.handihealth.org
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Medical device directive and theimplications 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
Denitions and concepts
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 ofbusiness.
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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 specically 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:
diagnosis, prevention, monitoring, treatment or
alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
investigation, replacement or modication of the
anatomy or of a physiological process
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Control of conceptionwhich 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 itsfunction by such means;
Dose the POPE know he should register the rythm
method as a medical device
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DSCN 14/2009
Application of Patient Safety Risk Management to the
Manufacture of Health Software
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
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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 intendedduring that time such information is likely to be sufcient
to cover this requirement
ModulesSome stand alone software may break down into a
signicant 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 thewhole software structure, other devices or equipment, the whole
combination, including the connection system, must be safe andmust not impair the specied performances of the modules which
are subject to the medical device Directives.
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POST MARKET SURVEILLANCE
The Directive seeks to improve the protection of health
and safety of patients, by reducing the likelihood ofsimilar 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
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 nalinspection of the products concerned, as specied in
Section 3 and is subject to audit as laid down in Sections
3.3 and 4 and to Community surveillance as specied in
Section 5.
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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 u line has been
classied as a medical device because it lead to
patients receiving (or not) a medication.
CVS risk scope is almost certainly the same category.
Decision Support SoftwareComputer based tools which combines medical
knowledge databases and algorithms with patient
specic data.
They are intended to provide healthcare professionals
and/or users with recommendations for or information
on diagnosis, prognosis, monitoring and treatment ofindividual patients.
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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.
Drug dosing systemsTo calculate the drug dosage to be administered to a
specic patient and therefore are qualied as medical
devices.
This would include drug doses lter by age sex gender
indication.
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Placing on the market:the rst 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.
Expert function software:software which is able to analyse existing information
to generate new specic information according to the
intended use of the software.
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.
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Summary
If an APP inuences a Clinician and probably also a
Patient that results in subsequent therapy you should
seriously consider if it is covered by the MDD and seekexpert guidance
Clinical safety and quality management systems together
with post marketing survelance are critical to the process.
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