1. Department of Engineering
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. 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

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

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 Research Governance Manager Addenbrooke’s Hospital – Louise Stockley

30. Useful websites
devices devices/files/meddev/2_4_1_rev_9_classification_en.pdf review-of-investigations-of-medical-devices/