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Introduction The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4)..

Background on post-market surveillance globallyPMS has been a pivotal topic. The European regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)) officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifec..

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for endosseous dental implants and abutments will have the option to use the performa..

We last wrote about the U.S. FDA eSTAR when it became compulsory for 510(k)s. At the time, the eSTAR was voluntary for De Novos. Background on De NovosThe De Novo Classification Request “De Novo” is the regulatory mechanism used when manufacturers have a novel medical device that they expect is not high risk and so should be Class II (special controls and general controls) or Class I (general co..

We at Emergo by UL would like to point out that the U.S. Food and Drug Administration (FDA) has recently adapted certain searches and information to highlight regulatory guidance for specific medical device types. Medical device and IVD manufacturers who want to stay ahead of regulatory changes to avoid market access disruptions should take note.  Searching FDA guidance documentsThe U.S. FDA  ha..

The U.S. Food and Drug Administration (FDA) issued a new draft human factors engineering (HFE) guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, on July 8, 2024. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a ..

The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization.  This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more informatio..

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devic..

Global harmonization continues to excite us all. And, global harmonization of medical device registration submissions is one way to advance the objectives of the International Medical Device Regulators Forum (IMDRF) and regulatory reliance. These documents are a must-read for any serious regulatory professional. Here we elaborate on our regulatory update featured in April 2023.  Background on IM..

Introduction: scope and contents  This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The contents of this document:  are not intended to be exhaustive, and must be read and used within the legal and guidance framework on EU ..