QUOTED. Sept. 5, 2018. Sarah Sorrel.
Post-market clinical follow-up (PMCF) is a relatively new requirement for the EU medtech sector – it's detailed for the first time in the new Medical Device and IVD Regulations. See what leading EU expert and clinical data consultant Sarah Sorrel said about PMCF here.
"Without the delegating acts, it is not entirely clear when PMCF will be mandatory under the [EU Medical Device Regulation]. This is a problem for manufacturers who need to plan now and to decide whether the cost of PMCF would warrant taking certain products off the market in view of the increased cost of compliance." –Sarah Sorrel, president, MedPass International
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