Meteriovigilance is the term used in the context of surveillance of medical devices and its purpose is to improve the health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device. Presented below in brief is the Post-Marketing regulatory landscape as exists for USFDA and EMA in terms of Medical Device Reporting.
References
- 21 CFR Part 803 — Medical Device Reporting
- 21 CFR Part 806 — Medical Devices; Reports of corrections and removals
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems (assessed on 17-Oct-2023)
- REGULATION (EU) 2017/745: Medical Devices Regulation https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices (assessed on 17-Oct-2023)
Author
Disha Dangwal - Manager- Clinical Safety and Pharmacovigilance
Disha is a pharmacist with 9+ years of pharmacovigilance experience. She is skilled in processing and review of spontaneous, clinical trial, global literature, E2B, medical device, and cosmetic reports. She has experience in reporting of cases to the US, Canada, EU, UK, and Australia. She has managed various projects and participated in several client audits and regulatory inspections as a lead representative and Subject Matter Expert.
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