Apr 25, 2011
The National Institute for Health and Clinical Excellence (NICE), an organization providing health care-related guidances and standards in the UK, has published guidelines explaining the process and methods of its Medical Technologies Evaluation Programme (MTEP) designed to promote efficient and consistent uptake of medical technologies within the National Health System (NHS).
The NICE guidelines should prove especially relevant to medical device and technology manufacturers interested in adding their products to the program, according to the organization. NICE developed the guidelines through consultation with the NHS, industry representatives, academia and patient advocates.
In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK.
The UK’s Academy of Medical Sciences has issued a new report recommending the consolidation of medical research regulations and governance under a single entity. The Academy’s report, “A new Pathway for the Regulation and Governance of Health Research,” includes five key components:
A UK Department of Health review of how British regulators managed PiP defective breast implants has identified several regulatory improvements the Medicines and Healthcare Products Regulatory Agency (MHRA) should adopt to handle similar events in the future.
The UK Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.