Glossary: General

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Academic In Confidence

See ‘In Confidence Material‘.

Active Implantable Medical Device

Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Active Medical Device

Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Clinical Investigation

Any systematic investigation or study in human subjects, undertaken to verify the safety and performance of a device under normal conditions of use.

Clinical Investigation Plan

A document that includes detailed information on the rationale, aims and objectives, design and proposed analyses, methodology, and conduct of the clinical investigation.

Clinical Investigator

The person responsible for the conduct of a clinical investigation and who takes the responsibility for the health and safety of the subjects involved.

Commercial In Confidence

See ‘In Confidence Material‘.

Health Technology Assessment (HTA)

The systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making for a drug, medical device or clinical/surgical procedure.

Implantable Device

Any device which is intended to be totally introduced into the human body, by surgical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least thirty days is also considered an implantable device.

Indication

The defined use of a technology as licensed by the European Medicines Agency (EMA) or the European Commission as well as specific bodies in each country such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Medical Devices

All products, except medicines, used in healthcare to diagnose, prevent, monitor or treat illness or disability. For example, a device might be a pacemaker, knee replacement, X-ray or blood pressure monitor.

Medtech Innovation Briefing (MIB)

MIBs help support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. They include a description of the technology, how it’s used and its potential role in the treatment pathway.

A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.

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