The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products - many thousands of items used each and every day by healthcare providers and patients. For more information, see the MHRA devices webpages
Article 1 of Directive 2001/83/EC as amended defines a "medicinal product" as: "Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis" More information is available from the MHRA Borderline Medicines webpages
Medicines for Human Use (Clinical Trials) Regulations
The Medicines for Human Use (Clinical Trials) Regulations (2004) apply to research into the safety and/or efficacy of investigational medicinal products. Further information can be found in CTIMP, IMP and the Clinical Trials Tool Kit.
The Medicines and Healthcare products Regulatory Agency is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. Underpinning the MHRA's work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. They have statutory powers regarding the approval of drug / devices for license; approving CTIMPs under the clinical trials regulations and approval for medical device trials.
The deliberate infection of human volunteers with micro-organisms
Minimal risk can be defined as either: moderate likelihood of a hazard occurring with minimal impact, or low likelihood of hazard occurring with moderate impact or low likelihood of low impact.
Monitoring should be built into the conduct of the study as a means to minimise risk, and should be ongoing and performed by members of the research team and people independent to it.The process of monitoring a study should ensure that the rights and wellbeing of any participants are protected, the reported data are accurate, complete, and verifiable from source documents, and that the conduct of the study is in compliance with the approved protocol/amendments, with GCP, and with the applicable regulatory requirements.
Medical Research Council