envelope  Contact us

phone1-301-495-0477

Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.

IMDRF International Medical Device Regulators ForumFollowing in this path, the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world whose work aims to accelerate international medical device regulatory harmonization and convergence, recently published a new guideline meant to improve the detection of medical device adverse events ( AEs).

The 14 page document was prepared by the IMDRF Adverse Event Working Group, charged with developing a harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).

The reason behind the guideline is summarized in its introduction: “Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory agencies”. Innovation triggers changes and the Medical Device Industry more than any other industry, follows the course of demands and sees new technologies emerge every day. With it, the nature and cause of issues triggered by medical device and their evaluation and monitoring require some adaptations.

The IMDRF in this document provides terms, definitions and “ IMDRF alpha-numerical codes to describe issues used in Adverse Event (AE) reporting for medical devices and in vitro diagnostics for both pre and post market. With this guideline, the IMDRF wishes to: 

  • Improve the accuracy of capturing and reporting adverse events for medical devices
  • Reduce the ambiguity and increase the effectiveness of the evaluation process for AEs
  • Provide a readily usable tool to signal detection and allow a faster response from the Regulatory Authorities and Medical Device Manufacturers.

The IMDRF argues that the use of harmonized terminology and associated codes will benefit not only Medical Device manufacturers (including local Distributors and Authorized Representatives, but also, Regulatory Authorities, Patients and Healthcare providers

Table 1: Overview of the four terminologies comprising the complete terminology for adverse event reporting.

Nr.

Name of
terminology

Description

Annex

Coding system

1

Medical device
problem

Terms/codes for describing
problems (malfunction,
deterioration of function,
failure) of medical devices that
have occurred in pre- or post market contexts (e.g. clinical
studies, clinical evaluation or
post-market surveillance)

A

A|00[00][00]

2

Cause investigation

underdevelopment

B – to be
developed

B|… (to be defined)

3

Patient Problem

underdevelopment

C – to be
developed

C|… (to be defined)

4

Component

underdevelopment

D – to be
develop

 

Source : http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-aer-n43.pdf

 

It is however expected that the changes made to the Adverse Event terminology are to be restricted to the absolute necessary, the adaptation to the industry evolution, and IMDRF doesn’t foresee frequent changes in the upcoming years.

Source : http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-aer-n43.pdf

MDSAP Prepare the transition, worldwide market access

Combo Training ISO13485 MDSAP

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register