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Guidance documents
MEDDEV MEDDEV documents
encompases the consensus of various working groups that are established by the European
Commission to elaborate guidelines on the application of the 'MEDical DEVices' EC
directives.These documents are revised from time to time to reflect changing needs.
All these documents are available and may be downloaded from:
http://ec.europa.eu/enterprise/sectors/medical-devices/documents/guidelines/index_en.htm
NB-MED NB-MED documents comprise of recommendations
accepted by the European Forum of Notified Bodies Medical Devices (NB-MED). These
recommendations are are not mandatory. Although they set out information on matters
relating to the directives this is for guidance only, to help you to meet your
obligations, whether you are a manufacturer, notified body or interested party.
All these documents are available and may be downloaded
from:
Team NB European Association of
Notified Bodies for Medical Device website.
The current Notified Bodies Medical Devices (NB-MED) Recommendation document regarding
Technical Documentation can be downloaded from:
(NB-MED/R2_5_1-5_rev4'Technical
documentation' (PDF, 156 KB)
GHTF The Global Harmonization Task Force (GHTF) is a voluntary
international consortium of public health officials responsible for administering national
medical device regulatory systems and representatives from the regulated industry. Since
its inception, the GHTF has been comprised of representatives from five governments
(grouped into three geographical areas, ie. Europe, Asia-Pacific and North America), each
of which actively regulates medical devices under their own unique regulatory system.
The purpose of the GHTF is to encourage convergence in regulatory practices related to
ensuring the safety, efficacy/performance and quality of medical devices, promoting
technological innovation and facilitating international trade, and the primary way in
which this is accomplished is via the publication and dissemination of harmonized guidance
documents on basic regulatory practices. These documents, which are developed by four (4)
different GHTF Study Groups (see Organizational Structure for more information), can then
be adopted/implemented by member national control authorities.
The GHTF also serves as an information exchange forum through which countries with medical
device regulatory systems under development can benefit from the experience of those with
existing systems and/or pattern their practices upon those of GHTF founding members
All these documents are available and may be downloaded from
GHTF
(Global Harmonisation Task Force) website.
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