IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)

1. Regulation of Software
Rob Higgins

2. 2
DEVICES: PERSPECTIVE
• 500,000 + devices on market
• 1/25 has an implant
• £11 billion UK
• £200 million maintenance
• > £460 million negligence

3. 3
Directives for Medical Devices
3 Directives:
• Active Implantable Medical Devices (90/385/EEC)
Powered implants
• Medical Devices (93/42/EEC)
Most other devices
• In Vitro Diagnostics (98/79/EC)
In Vitro Diagnostic Products

4. Summary of Directives
• Single market provision, based on mutual recognition and
removal of national measures
• specify essential requirements
• introduce controls covering the safety, performance,
specification, design, manufacture and packaging of devices
• specify requirements for assessment of clinical investigation
protocols

5. Summary of Directives (Cont)
• specifies requirements for the evaluation of any adverse incidents
that occur (Vigilance)
• introduces a system of classifying devices, and applies a level of
control which is matched to the degree of risk inherent in the
device
• introduces the concept of Notified Bodies who check and verify
that manufacturers and devices meet the relevant requirements
• Introduces a system of registration of medical devices

6. Manufacturer
• Reviews and complies with relevant Essential Requirements
• Implements systems
• If applicable applies to Notified Body for Assessment, test
• Makes Declaration of Conformity
• If applicable registers product with relevant Competent Authority
• Applies the CE Marking
• Operates Post Market Surveillance and Vigilance

7. Notified Body
Pre Market :
• Assessment against the particular Annex(es)
for Specified Product Range
• Issues Annex Approval(s)
• Batch Review of Highest Risk IVD Products
Post Market :
• Ongoing Surveillance (if QA Annex)
• Approves Changes
• Co-Regulator

8. Competent Authority
Notified Bodies : Initial Designation
: Ongoing Surveillance
Pre Market : Registration
: Clinical Investigation
: Review of TSE Summary Reports
Post Market : Vigilance
Throughout : Enforcement

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Risk Classification
• Low Risk – Class I
Plasters, Walking Sticks, Wheelchairs, Stethoscopes, Medicine Spoons,
Administration Sets, Syringes, Re-usable Surgical Instruments
• Medium Risk – Class IIa and IIb
Needles, Dental Filling Materials, Contact Lenses and Solutions,
Diagnostic and Monitoring Equipment, Condoms, Infusion Pumps, Blood Bags,
Haemodialysis Concentrates, Hearing Aids, Ventilators, Incubators, Surgical
Lasers, Anaesthetic Machines, Nebulisers
• High Risk – Class III and active implantables
Pacemakers, Cochlear Implants, Breast Implants, Devices containing
Medicinal Substances, Devices containing Animal Materials, Cardiovascular and
Devices, Neurological Implants, Absorbable Sutures

10. 10
EU REGULATORY SYSTEM
compliance ERs
safety, performance Notified Body
• quality systems
• design dossier
• clinical data (literature, C/I)
accredit
audit
Competent
Authority
European market
post market surveillance
serious adverse events
investigation
action

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EU MARKET
compliance with all Essential
Requirements covering safety
and performance

12. Definition
“software… 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 modification of the
anatomy or of a physiological process,
•control of conception….”
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13. Apps
The words and phrases listed below are all likely to
contribute to a determination by the MHRA that the
app they were associated with is a medical device:
amplify analysis interpret
alarms calculates controls
converts detects diagnose
measures monitors
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14. Apps (Cont)
Decision support or decision making software that applies
some form of automated reasoning, such as a simple
calculation, a decision support algorithm or a more complex
series of calculations, e.g. dose calculations, symptom
tracking, clinicians guides. These are the types of software
most likely to fall within the scope of the medical devices
directives.
This includes software which provides personalised guidance
based on information it has about a specific individual and
makes use of data entered by them, provided by point of care
devices or obtained via health records.
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15. Apps (Cont)
Apps acting as accessories to medical devices such
as in the measurement of temperature, heart rate,
blood pressure and blood sugars could be a medical
device as are programmers for prosthetics.
Software that monitors a patient and collects
information entered by the user, measured
automatically by the app or collected by a point of
care device may qualify as a medical device if the
output affects the treatment of an individual.
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16. Apps (Cont)
Software that provides general information but does
not provide personalised advice, although it may be
targeted to a particular user group, is unlikely to be
considered a medical device.
Software that is used to book an appointment,
request a prescription or have a virtual consultation is
also unlikely to be considered a medical device if it
only has an administrative function.
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17. Apps (Cont)
Some decision support software may not be
considered to be a medical device if it exists only to
provide information to enable a healthcare
professional to make a clinical decision as they
ultimately rely on their knowledge. However, if the
software or app performs a calculation or interprets or
interpolates data and the healthcare professional
does not review the raw data, then this software may
be considered a medical device.
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18. Validation and Verification
It is essential that appropriate validation and
verification activities are performed ie
Pre – clinical testing
Clinical Evaluation including, if necessary, clinical
investigations
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ESSENTIAL REQUIREMENTS
“the devices must be designed in such
a way that….they will not compromise
the clinical condition or SAFETY of
patients…...provided that any RISKS
which may be associated with their
use constitute acceptable RISKS
when weighed against the benefits…”
MDD: Annex 1
…..devices must achieve the performance
intended by the manufacturer…..

20. Classification
• All software is considered to be ‘active’
• Implementing rule 2.3 - Software, which drives a
device or influences the use of a device
automatically falls into the classification of that
device.
• Rule 9 - Active therapeutical devices are generally
Class IIa – however if potentially hazardous then
Class IIb.
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21. Classification (Cont)
• Rule 10 - Active devices intended for diagnosis are
generally Class IIa – however if potentially
hazardous then Class IIb.
• Rule 12 - All other Active Devices are class I.
• Rule 14 - All devices used for contraception or the
prevention of the transmission of sexually
transmitted diseases are in Class IIb.
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22. Post Market Surveillance
Manufacturers have a responsibility to implement an
effective post-market surveillance system to ensure
that any problems or risks associated with the use of
their device once freely marketed are identified early,
reported to competent authorities, and acted upon.
This is known as the
medical devices vigilance system.
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Rob.higgins@mhra.gsi.gov.uk