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.

References

  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)

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.

Download This Article

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.

Disclaimer

Copyright 2023 by Soterius, Inc. All rights reserved. Soterius logo are trademarks or registered trademarks of Soterius in all jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners. The information you see, hear or read on the pages within this presentation, as well as the presentation’s form and substance, are subject to copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of Soterius. No license or right pertaining to any of these trademarks shall be granted without the written permission of Soterius (and any of its global offices and/or affiliates). Soterius reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights.
 
Any content presented herewith should only be considered for general informational purposes and should not be considered as specific to the requirements of any particular organisation or for any specific purpose. Soterius does not make any representations or warranties about the completeness, reliability, appropriateness, relevance, or accuracy of the content presented here.

Like this article?

Share on Linkedin
Share on Facebook
Share on Twitter
Share on Email

What Can We Do For You?

Get the latest presentation of our service capabilities and technology assets.

Get Brochure
Scroll to Top