EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
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Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.
Author: Informa Pharma Intelligence
Publisher: MedTech
- Description
Medtech interviewed Sarah Sorrel, a leading EU expert and consultant on clinical data issues to better understand what Post-market clinical follow-up (PMCF), a relatively new requirement for the EU medtech sector, will entail. Sorrell, president of MedPass International, discusses how slow implementation of the new regulations is making it difficult for manufacturers to put post-market plans into place and leverage the potential value of PMCF to help obtain recertification of devices. The interview previews some of the themes at the 3rd European Symposium on New Medical Device Regulations in Brussels.
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