Guidelines

HTA of MDs
Health Technology Assessment of Medical Devices


HTA is multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a health technology in health care.

The term Health Technology refers to application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.



Library of Assessments on MDs (1999-2020)

23 Entries into category "guidelines"

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Understanding Health Technology Assessment (HTA)

This guide describes how patients and the public can get involved in decisions about what healthcare should be available. It can also be used to help raise awareness of patient needs. Purpose of the guide This practical guide describes the contribution that patients, caregivers and the public can make to decisions about improving healthcare, based on […]

Conformity assessment procedures for hip, knee and shoulder total joint replacements

INTRODUCTION It is the primary purpose of this document to provide guidance to Manufacturers and Notified Bodies in dealing with the application of Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements adopted by the European Commission on 11 August 2005, hereafter referred to as the Directive3 and taking into account the MEDDEV. […]

Medical device regulations: global overview and guiding principles

Summary of contents Chapter 2 describes the nature of medical device safety as a risk management process that must encompass the life span of medical devices from their conception to disposal. A Life Span Diagram facilitates understanding and serves as a memory anchor. Optimum safety and performance require cooperation among all those involved in the life span of a […]