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WebFor devices in Classes C and D (new Article 81), the main outputs of the new Periodic Safety Update Report (PSUR) are prescribed. They including the conclusions of the benefit-risk determination and the main findings of the Post Market Performance Follow-up (PMPF) activities. The frequency with which the new PSUR must be updated is also defined. WebSep 4, 2024 · Post-market clinical follow-up (PMCF) is a relatively new requirement for the EU medtech sector. It is detailed for the first time in the EU's new Medical Device and IVD Regulations. In this interview, Sarah Sorrel, a leading EU expert and consultant on clinical data issues, discusses with Medtech Insight what PMCF will entail. cse petroineos lavera
MDCG 2024-9 - Public Health
WebAug 24, 2024 · Since the main goals of PMPF are to confirm the safety, performance and scientific validity of your device, PMPF may not be needed if the safety of the device when … WebApr 13, 2024 · PORTARIA N° 066 3 DE DE ABRIL DE 2024. Altera o Anexo Único da Portaria n° 202/2024, de 14/10/2024 (DOE 25/10/2024), que institui e divulga lista de Preços Médios Ponderados a Consumidor Final - PMPF, para fins de determinação da base de cálculo do ICMS devido por substituição tributária nas operações com cimento, e dá outras … WebPMPF is just one page in the PMS story. The best way to tackle any component of post-market surveillance is to do it with the whole story in mind because this is how notified … marcha antialgica definicion