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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 mitigation of risk of shortages of in vitro diagnostic medical devices (IVDs) needed for the smooth functioning of healthcare service..

BackgroundThe Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3. The document now covers devices regulated under the IVDR. As Emergo by UL reported last year, the initial version of MDCG 2023-3 explicitly excluded IVDs from its scope. Guidance on vigilance reporting for IVDsThe guidance now includes IVD-specific examples of incidents, se..

Introduction This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requireme..

Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents. It has been a busy October month for the European Commission (EC) and for stakeholders participating in the relevant Medical Devices Coordination Groups (MDCG). With the adoption of Regulation (EU) 2024/1860, not only the transitional timelines for ..

It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.  What the MDCG document regulating steril..

1. Introduction The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical devices, in vitro diagnostic medical devices ..

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..

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  This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereafter IVDR). It should be read in conjunction with the guidance document MD..

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)..