medical devices for the safety standards and codes

1. Medical Devices
Department of Engineering
February 11th 2015

2. Medical Devices
• What is a medical device
• Approvals required for studies involving medical
devices
• Who and how are they regulated

3. 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

4. Examples of medical
devices
• Implants
• Dressings
• Patient Monitoring equipment
• X ray systems
• Wheelchairs
• Hearing Aids
• Devices for blood glucose measurements

5. 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

6. 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)

7. 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?

8. • 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
APPs as medical devices

9. • 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

10. 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

11. Manufacturer
Person responsible for the design, manufacture,
packaging and labelling of a device before it is placed
on the market

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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
Victoria.Hollamby@admin.cam.ac.uk

18. 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

19. 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

20. 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

21. 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) .

22. Class IIa and IIb
Safety and performance needs to be adequately
demonstrated – may need clinical investigation if
insufficient existing clinical data

23. 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

24. 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

25. 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

26. Organisations
Competent Authority – MHRA
Notified Body – CE Marking
Ethics – Health Research Authority NRES
NHS - R&D

27. 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)

28. Notified Bodies
Check manufacturers of medium and high risk devices
have followed the requirement
Issue CE marks for these devices

29. Useful contacts
Research Governance Officer – Carolyn Read
cad50@medschl.cam.ac.uk 01223 769291
Research Governance Manager Addenbrooke’s
Hospital – Louise Stockley
louise.stockley@addenbrookes.nhs.uk

30. Useful websites
https://www.gov.uk/government/collections/regulatory-guidance-for-medical-
devices
http://ec.europa.eu/health/medical-
devices/files/meddev/2_4_1_rev_9_classification_en.pdf
http://www.hra.nhs.uk/
http://www.hra.nhs.uk/resources/before-you-apply/types-of-ethical-review/ethical-
review-of-investigations-of-medical-devices/