1 Introduction

1 Introduction

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.

NICE selects and evaluates medical technologies to determine whether evidence supports the case for adoption in the health and social care system. For the purposes of the medical technologies evaluation programme (MTEP), a medical technology is defined as outlined in table 1.

Table 1 Definitions of medical technologies for the programme

Term

Definition

Source

Medical device

'Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or [disability]

  • investigation, replacement or modification of the anatomy or of a physiological process

  • control of conception

  • and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.'

European Parliament and the Council of the European Union (2007) Council Directive 2007/47/EC of 5 September 2007 amending Council Directive 93/42/EEC concerning medical devices.

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.'

Council of the European Communities (1990) Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC).

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.'

Council of the European Communities (1990) Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC).

In vitro diagnostic medical device

'Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • concerning a physiological or pathological state, or

  • concerning a congenital abnormality, or

  • to determine the safety and compatibility with potential recipients, or

  • to monitor therapeutic measures.'

European Parliament and the Council of the European Union (1998) Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices.

A diagnostic technology is any medical technology with a diagnostic purpose. Diagnostic technologies are a subset of medical technologies.

MTEP covers genetic tests only if they are used for a medical purpose and fall within the scope of Directive 98/79/EC (in vitro diagnostic medical devices).

MTEP identifies medical technologies that have the potential to offer substantial benefit to patients and/or to the health and social care system, and that are likely to be adopted more consistently and more rapidly if NICE were to develop guidance or advice related to them.

This methods guide describes how NICE selects medical technologies for development of NICE guidance. It also describes how the medical technologies advisory committee develops guidance on selected technologies routed to it. The methods are designed to ensure that the most appropriate medical technologies are selected for evaluation, and that any guidance produced is robust, developed in an open, transparent and timely way, takes into account valid and relevant evidence, and allows appropriate input from consultees and other stakeholders. This methods guide should be read in conjunction with the MTEP process guide.

Nothing in this document will restrict any disclosure of information by NICE that is required by law (including, in particular but without limitation, the Freedom of Information Act 2000).