Medical Device means "an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which –
a) is intended by the manufacturer to be used for human beings for the purpose of
i. diagnosis, prevention, monitoring, treatment or alleviation of disease,
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
iii. investigation, replacement or modification of the anatomy or of a physiological process, or control of conception; and
b) Does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means".
It is important to read the documents below published in February 2011 by the MHRA for more information. Further information can also be found on the MHRA website.
Definition of Manufacturer
" the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party". The obligations of a manufacturer under these Regulations also apply to any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient"
Medical devices are currently regulated by three EU Directives which are intended to ensure that a Device does not compromise the clinical condition or safety of the patient, the safety and health of users, and where applicable any third party. The Directives also ensure that a Device achieves its intended purpose as designated by the manufacturer, and any risks associated with the use of the Device are acceptable when weighed against the benefits to the patient and compatible with a high level of protection of health and safety. The three Directives are:
- Active Implantable Medical Devices
This Directive covers all powered medical devices implanted and left in the human body, such as pacemakers, implantable defibrillators, implantable infusion pumps, cochlear implants and implantable neuromuscular stimulators.
- Medical Devices
This Directive covers most other medical devices ranging from simple bandages to orthopaedic implants and high-technology radiology equipment
- IN VITRO Diagnostic Medical Devices
This Directive covers any medical device, reagent, reagent product, kit, instrument, apparatus or system which is intended to be used in-vitro for the examination of substances derived from the human body, such as blood grouping reagents, pregnancy testing and Hepatitis B test kits.
Researchers wanting to conduct a study involving Medical Devices, should contact their R&IS Departmental Officer. Checks are essential to ensure compliance with University Policy and Regulations (including the University's financial regulations and the research governance framework), and to ensure there is adequate insurance cover. Warwick Ventures may need to be consulted on protection and commercialisation of Intellectual Property Rights.
The MHRA charge fees for the pre-clinical assessment of clinical investiation notifications.
For Clinical Investigations into the safety and performance of non CE marked devices, an application must be made to the Medicines and Healthcare products Regulatory Agency (MHRA) a minimum of 60 days prior to the estimated project start date. Complete your application through IRAS, one hard copy of the application with wet ink signatures (electronic authorisation is not permissible), plus eight rewritable CD-ROMs are required to be sent to the MHRA. The 60 day assessment period will commence from the day the MHRA are in receipt of all these items. Notifications of Clinical Investigations should be sent to:
Regulatory Affairs Manager (Medical Device Clinical Trials)
5 Magenta, 151 Buckingham Palace Road, Victoria,
London, SW1W 9SZ
For ALL clinical investigations of devices falling within the scope of the Medical Devices Directive, Research Ethics Committee (REC) approval is mandatory, and this must be a REC approved by National Research Ethics Service (now part of the NHS Health Research Authority). Submission can be in parallel with the items required by the MHRA through IRAS.
If the MHRA raise any objections to the project but the REC have approved it, then the project must not commence until issues have been resolved.
Labelling of Medical Devices
All devices intended for clinical investigation must bear the wording “exclusively for clinical investigation”. It is recognised that such wording may give scope for misunderstanding as to the nature of the clinical investigation, in that it may be thought that the investigation being referred to is of a patient rather than the device. All clinical investigators should therefore ensure that the meaning of this wording is clearly understood by all staff using or coming into contact with the device being investigated and that the device under investigation is segregated, where possible, from devices in routine use. In some cases the clinical investigator may consider it necessary to attach appropriate warning signs to the device under investigation. Devices intended for clinical investigation may not bear the CE marking
The purpose of the adverse incident reporting system under the provisions of the Medical Devices Directives is to protect the health and safety of patients and users. Any adverse incident involving a medical device undergoing clinical investigation should be reported to the manufacturer, or directly to the Medicines & Healthcare products Regulatory Agency Adverse Incident Centre (Tel: 020 7084 3080; Fax 020 7084 3109) via the MHRA on-line system.