e.alvarado2022-08-04T14:21:10+00:00June 28th, 2022|Categories: Meditrial|Tags: Clinical Trial, Devices, GCP, Good Clinical Practice, IN-VITRO, IVD, IVDR, Medical Devices|
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]
e.alvarado2022-07-05T08:28:58+00:00June 22nd, 2022|Categories: Meditrial|Tags: CLINICAL PRACTICE, Devices, EDC, EU-MDR 2017/745, MDR, Medical Devices, PMCF, PMS, Post-market clinical follow-up, Post-market surveillance, Postmarketing, Surveillance|
After more than 20 years, new legislation, the "Medical Device Regulation" (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related [...]
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