This guideline on “Therapeutic medical devices”, with answered comments from the SAG / Public consultation, is the last guideline of WP7 Subgroup 3 in JA2.
Guideline: Therapeutic medical devices | EUnetHTA
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23 Entries into category "Guidelines"
Appropriate Use of Hand-Held Wireless Devices in Health Care Settings: Guidelines
RESEARCH QUESTION What are the evidence-based guidelines associated with the appropriate use of hand-held wireless devices for the delivery of patient care in a variety of health care settings? KEY MESSAGE Four systematic reviews were identified regarding...
Health Technology Assessment of Medical Devices. (WHO Medical Device Technical Series)
Health technology assessment (HTA) has emerged as an important tool for supporting the core functions of an effective global health system. Actions by the World Health Organization (WHO) and other global health organizations are necessary to support regional and...
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,...
Guidelines on Medical Devices
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Introduction Pursuant to - section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to - section 5a of Annex 1 to Directive 90/385/EEC (amended by...
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...
Principles of Conformity Assessment for Medical Devices
This document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. The...
WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices
The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed...
WHO technical specifications of neonatal resuscitation devices
The WHO technical specifications of Neonatal Resuscitation Devices was developed under the framework of the World Health Assembly Resolution WHA66.7, (5) which is at the foundation of the United Nations Commission on Life-Saving Commodities (UNCLSC) for Women and...
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...
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