Overview of Regulatory Requirement for Post-Marketing Medical Device Reporting in the USA and the EU

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.


  1. 21 CFR Part 803 — Medical Device Reporting
  2. 21 CFR Part 806 — Medical Devices; Reports of corrections and removals
  3. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems (assessed on 17-Oct-2023)
  4. REGULATION (EU) 2017/745: Medical Devices Regulation https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices (assessed on 17-Oct-2023)


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.

About Soterius

Soterius is a strong team of pharma professionals who design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence in pioneering customer centric solutions. Our innovative technology solutions include engagement tools and communications platforms to create a unified and compliant medical access facility. With a strong global presence, we provide comprehensive clinical and post marketed safety services, that include aggregate report writing, signal detection and management, global literature surveillance, risk management, case processing and regulatory reporting. We use state-of-the-art technologies to solve complex safety operations problems, be it case processing, intake, site reporting for clinical trials, or literature search and management. We have one of the most accurate solutions for case intake and case processing using AI.
We support companies from the initial development stage of a drug/vaccine to the approval and ultimate marketing of the therapy, supporting ongoing operations and regulatory commitments globally.

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