Oct 19, 2022
Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast developme
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Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast developme
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Regulatory Affairs Professionals Society Blog (26/03/2019)
CDRH Proposes New IMDRF Work Item on Standards
… The NWI proposal (NWIP) seeks to set new parameters for IMDRF to serve as liaison to the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). It comes after IMDRF became liaison to ISO TC210—the working group on ISO 13485—and to IEC TC 62 last year.
Common Data Elements for Medical Device Identification
Common Data Elements for Medical Device Identification
International Medical Device Regulators (IMDRF) Forum PROPOSED DOCUMENT Common Data Elements for Medical Device Identification
Date: 8 July 2015
This document outlines the common data elements for medical device identification that may be used through regulatory activities or process (pre-market, and post-market), including the future possibility of electronic regulatory submission of device…
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IMDRF IVD Table of Contents for Marketing Authorization Submissions
IMDRF IVD Table of Contents for Marketing Authorization Submissions
In Vitro Diagnostics Medical Device (IVD) Market Authorization Table of Content for Submissions
30 June 2014
This document is an internationally harmonized, modular, format for use when filing medical device submissions to regulatory authorities for market authorization.
PREFACE
The document herein was produced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of…
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