New Adverse Event Reporting Procedures

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition

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Adverse events always happen in the device manufacturing process, but the way companies must report them is changing. The FDA has officially transitioned from its traditional medical device report (MDR) coding system to the newly developed International Medical Device Regulators’ Forum (IMDRF), and devicemakers in the U.S. and EU must now use this structure and the related reporting methods.

This is a big change but this FDAnews report can get you on the right track.

IMDRF’s members, medical device regulators from around the globe, built the system as a way to standardize medical device reporting and while the FDA and the EU are the first entities to implement the new coding, the intent is that the structure will be adopted globally.

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition will provide a detailed explanation of the new set of codes, which are organized in a tree-like hierarchy. It will show you how to adapt to the changes to the FDA’s electronic submission methods and the EU’s new reporting form. With a series of diagrams and hypothetical examples, the report will provide the details you need to successfully navigate reporting adverse events.

Key management report takeaways:

  • IMDRF Basics
    1. The seven code sets and an explanation of their structure
    2. Reporting terminology

  • FDA Reporting Requirements
    1. Planned adjustments to FDA’s reporting form
    2. Six general elements of FDA reports
    3. The relationship between the IMDRF codes and current FDA codes
    4. The consequences of a wrong code in the FDA reporting system

  • The EU Manufacturer’s Incident Report (MIR)
    1. The IMDRF codes used in the EU’s MIR
    2. The difference between an incident, complaint and serious incident in the EU

  • Code Compliance Documents
    1. The IMDRF code guide and annexes
    2. A copy of the MIR form and guidance

The shift to the IMDRF and MIR has come — and there is no avoiding the adjustments any devicemaker in the U.S. and the EU must make. Follow the advice in New Adverse Event Reporting Procedures and guide your team through the changes in a productive and relatively painless manner.

Find the resource you need to navigate this process here.

Who Will Benefit

  • Medical device manufacturers
  • Quality unit professionals
  • Compliance management departments
  • Recalls and corrections professionals
  • Regulatory affairs staff
  • Legal professionals
  • Postmarket safety professionals

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ISBN-13:
978-1-60430-153-3

Publication date:
Nov. 2020

Page count:
51


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