Medical Devices

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. 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 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/