Medical Devices

Department of Engineering
February 11th 2015
 Medical Devices

• What is a medical device

• Approvals required for studies involving medical devices

• Who and how are they regulated

 What is a medical device

• “Medical Device” covers all products, except medicines,

used in healthcare for the diagnosis, prevention,
monitoring or treatment of illness or disability
 Examples of medical devices
• Implants

• Dressings

• Patient Monitoring equipment

• X ray systems

• Wheelchairs

• Hearing Aids

• Devices for blood glucose measurements

 Examples of products that can be both a
medical device and non medical device

• Personal protective equipment

• Who are you protecting?
• what is the principal stated purpose of the product by the
manufacturer?
• Rubber/latex gloves
• Marigolds = general purpose so not medical device
• surgical gloves = medical device
 Stand alone software

• Software which is not incorporated in another medical

device but has a medical purpose

• Directly controls apparatus (radiotherapy)

• Provides immediate decision triggering information

(blood glucose meters)

• Provides support for healthcare professional (ECG

interpretation)
 Decision tree for standalone
software
• Is it a computer programme?

• Does the programme perform an action on data?

• Is it for the benefit of an individual patient - will it

evaluate patient data to support or influence the medical
care provided to that patient?
 APPs as medical devices
• Words associated with a medical device

• amplify, analysis, interpret, alarms, calculates,

controls, converts, detects, diagnose, measures,
monitors

• Software that applies some sort of automated reasoning

- calculation, dose calculation, algorithm, clinicians
guide
• Software that provides personalised guidance

• makes use of information entered by the patients,

provided by point of care devices or obtained via
health records, if it affects the treatment of the
patient

• If the software performs a calculation or interprets data

and the healthcare provider does not review the raw
data = medical device
 Intention to “place on
market”
Research with the intention to “commercialise” the device
or

“place on the market” – make available in return for

payment or free of charge, with a view to distribution, use
or both

Requires MHRA approval

 Manufacturer

Person responsible for the design, manufacture, packaging

and labelling of a device before it is placed on the market
 In house manufacture
• No intention to “put on the market” or place into service
under the manufacturer’s name

• There is no transfer of ownership of the product or

intention to give to another NHS Trust

• Not covered by medical device regulations but may be

covered by general research requirements if used in a
hospital

• Any data gathered cannot be used in a future MHRA

submission
Working with Addenbrooke’s
If the Chief Investigator is an Addenbrooke’s employee or a
researcher based at the Clinical School then this MAY be
considered “in house” manufacture

R&D approval

Clinical Engineering approval

Electronic safety standards must be met

Evidence of liability cover

 Research in a clinical setting

Any study recruiting participants from the NHS, using

patient data or patient tissue requires NRES ethics approval
and R&D approval

Any study using NHS facilities in a study requires R&D

approval

Any study using NHS staff as participants in a study

requires R&D approval and University ethics approval
 Research with patients
• Sponsorship

• Confirmation of Funding

• Appropriate peer review

• Favourable ethical opinion letter

• Confirmation of insurance for your study

• Confirmation of honorary research contracts

• Appropriate agreements with third parties

 Research Ethics
Proof of concept studies recruiting a small number of healthy
volunteers – internal ethics approval - but considered on a case by
case basis.

Studies recruiting a large group of healthy volunteers - no longer a

proof of concept study – MHRA assumption that there is an
intention to commercialise or “put on market” – NRES ethics
approval and MHRA approval

Clinical Investigation studies of medical device – NRES ethics

approval and may require MHRA approval
 Insurance

Whatever the setting, if you are using a medical device in

any type of research, it is important to ensure that
appropriate insurance is in place

Insurance contact: Victoria Hollamby

[Link]@[Link]
 Medical devices and
regulation
• Devices are categorised into classes according to the
degree of risk inherent in the device

• Class I - low risk – apps, standalone software

• Class 11a and 11b – medium risk

• Class III high risk

• The conformity assessment and the CE mark depend on

the Class of the product
 Classification
Depends upon a series of factors including:

How long the device is intended to be in continuous

use

Whether or not the device is invasive

Whether the device is implantable or active

Whether or not the device contains a substance

 Non invasive device
Class I - In contact with injured skin – provide mechanical
barrier, eg plasters, wound gauze

Class IIa - Intended to manage micro-environment of wound

– control moisture at wound, eg hydrogel dressings. Not for
extensive wounds

Class IIb - Intended for wounds which breach dermis and

heal only by secondary intent – severe burns eg temporary
skin substitute
 Class I

If you are satisfied that your medical device complies with

the requirements in the MDD, you must write a statement to
declare this – “Declaration of Conformity”

As 11th February 2015 new online application system for

Class I devices, (Device Online Registration System,
DORS) .
 Class IIa and IIb

Safety and performance needs to be adequately

demonstrated – may need clinical investigation if
insufficient existing clinical data
 Devices requiring clinical
investigation

Device is implantable or Class III medical device

Introducing new concept of device into medical practice

Existing device modified so a novel feature may have

important phsyiological effects or it affects clinical
performance and safety of the device
 Devices requiring clinical
investigation
Devices incorporating materials previously untested in
humans

Device, either CE marked or non CE marked, being

proposed for a new purpose or function

In vitro and/or animal testing of device cannot mimic the

clinical situation

New manufacturer, especially of a high risk device

 Medical Device Directives
90/385/EEC – Active Implantable Device Directive
(AIMDD) – covers all powered implants or partial implants
that are left in the human body – pacemaker

93/42/EEC – Medical Device Directive (MDD) – covers

most other medical devices

98/79/EC – In-vitro Diagnostics Device (IVD) – covers any

device which is a reagent, instrument, appparatus, for use
in-vitor for examination of speciments from the human body
- hepatitis B testing kits
 Organisations

Competent Authority – MHRA

Notified Body – CE Marking

Ethics – Health Research Authority NRES

NHS - R&D
 MHRA

Ensures compliance with regulations

Evaluates adverse incident reports

Pre-clinical assessment of devices intended for clinical trial

Designates the independent certification organisation

(notified bodies)
 Notified Bodies

Check manufacturers of medium and high risk devices have

followed the requirement

Issue CE marks for these devices

 Useful contacts
Research Governance Officer – Carolyn Read

cad50@[Link] 01223 769291

Research Governance Manager Addenbrooke’s Hospital

– Louise Stockley

[Link]@[Link]
 Useful websites

[Link]

[Link]
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[Link]

[Link]
of-investigations-of-medical-devices
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