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The selection of sites and investigators.
Post market clinical follow up report template. The post market clinical follow up pmcf template illustrates a guideline of the pmcf procedure including all the key requirements. This requires manufacturers to start post market clinical follow up pmcf activities to fulfil the requirements set out in annex xiv part b of the mdr. N a last update. Post market clinical follow up pmcf as per mdr article 83 is hard to understand so preparation of fully complying pmcf procedures and templates is hard for newcomers as well those who has less time to spend in research. Fri apr 24 09 38 42 cest 2020.
Thu apr 23 00 00 00 cest 2020 created by grow r 2 dir publication date. All post market clinical follow up studies should have a plan appropriate for addressing the stated objectives. Mdr eu 2017 745 compliant. The study plan should justify for example. Controls control groups where relevant.
A guide for manufacturers and notified bodies document date. The manufacturer is responsible to develop a continuously. Fri apr 24 09 36 39 cest 2020. A guide for manufacturers and notified bodies document date. The european medical devices regulation mdr will tie post market clinical follow up pmcf data more closely to post market surveillance and clinical evaluation report requirements.
The clinical evaluation procedure bundle includes standard operating procedures and forms relating to clinical evaluations post market clinical follow up post market surveillance and ce marking. It is carried out following the ce marking of a device. The postmarket clinical follow up study plan. Following which we present a practical guide to use for pmcf activities. Mdcg 2020 8 post market clinical follow up pmcf evaluation report template.
Mdcg 2020 7 post market clinical follow up pmcf plan template. N a last update. Post market clinical follow up pmcf is a part of the post market surveillance pms activity and is understood to be a continuous process that updates the clinical evaluation. Thu apr 23 00 00 00 cest 2020 created by grow r 2 dir publication date.
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