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Background In Jan. 2024, the U.K. medical device regulator, the MHRA, shared a roadmap detailing how it planned to implement future medical device regulations. In September 2024, Dr. Robert Reid, Deputy Director, MHRA, Innovative Device, provided attendees at the RAPS Convergence with an update on that roadmap.On Nov. 1, Dr. Laura Squire, Chief Healthcare Quality and Access Officer, MHRA, publis..

The demand for medication to be delivered using autoinjectors is rising internationally, responding to the increased incidence rates of chronic conditions and the emerging treatments for those chronic conditions. Autoinjectors are used to deliver medication to treat Rheumatoid Arthritis, Multiple Sclerosis, Anaphylaxis, Crohn’s Disease, among others. It is reasonable to assume that some autoinje..

1. BORDERLINE PRODUCTS: MEDICAL DEVICES / MEDICINAL PRODUCTS  1.1 IntroductionThe demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets of legislation and their correct interpretation and..

Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including the mitigation of risks related to discontinuation or interruption of supply of in vitro diagnostic medical devices (IVDs) needed fo..

You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC. In addition, the Heads of Medicines Agencies (HMA, heads of EU Competent Authorities responsib..

SummaryThe Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical an..

1. Introduction The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been amended by Regulation (EU) 2023/607. In particular, the transitional period has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028, depending on the risk class of the device and subject to certain conditions. This document provides updated guidance as regards the appl..

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)..

We present our insights from the past quarter. Advances in regulatory harmonization, as shared after the first three months and second three months of the year, continue. While it may have been a summer break for many, regulatory developments abound. This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI). Word of the day..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Regulation (EU) 2024/1860 and IVDR Compliance in Europe▶ 일시: 2024년 10월 16일 CST 9시 (한국시간: 10월 16일 23시)  Are you an IVD medical device manufacturer who needs a better understanding of what action you will need to take and when so that you can make use of the extension under the revised Regulation (EU) 2024/1860. The European Commission amended the In Vitro Diagnost..