Search results with tag "Market surveillance"
EUROPEAN COMMISSION DG Health and Consumers (SANCO ...
meddev.infomarket surveillance; ... The term "post-marketing surveillance" as referred to in Annexes 2, 4, 5 in AIMD has the ... National Competent Authorities outside Europe who are involved in the GHTF National Competent Authority Report (NCAR) exchange programme. These guidelines are relevant to INCIDENTs occurring within the Member States of the ...
IMDRF terminologies for categorized Adverse Event ...
www.imdrf.orgboth pre and post market as described in section 5. Notably, the precise criteria for reporting adverse events are defined by each regulatory authority and are not subject to this guidance document. Reference is made to the relevant guidance documents of each jurisdiction and the GHTF document on Post Market Surveillance:
Clinical Evaluation Reports from the medical writer’s ...
journal.emwa.orgpost-market surveillance (PMS) information. Summary Although it is the first section to be read, the summary is the last to be written. The summary should give a succinct overview of the clinical condition and state of the art; brief details of the subject device and its indication; conclusions of the evaluation pre-clinical studies, pre-market
GHTF SG2 Medical Devices: Post Market …
www.imdrf.orgFebruary 2009 3 / 13 Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form: GHTF/SG2/N79R11:2009
Global Medical Device Nomenclature (GMDN) - WHO
www.who.intGlobal acceptance? GHTF (now IMDRF) proposes GMDN for UDI EC proposes GMDN for the EUDAMED (market surveillance database) EUCOMED supports the use of GMDN in meeting the needs of European manufacturers