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[Emergo, UL] European Commission Releases New Management Incident Report Form and Help Text

MIR version 7.3.1 is releasedThe European Commission (EC) has at last released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the new report form, as well as the corresponding XSD and XML schema files to facilitate the integration of comp..

Introduction to the EUDAMED Workshop The European Commission is organising a free registration hybrid workshop in Stuttgart to support the EUDAMED onboarding of all concerned actors, in view of the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules of the system. The workshop will provide an overview of the obligations under the Medical Devices..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

The first three months of 2025 have ended and our team has been ardently sharing regulatory news. No particular regulatory update was heralded as groundbreaking (other than news of an agreement between the Malaysia Medical Device Authority (MDA) and China NMPA to ease regulatory requirements for certain classes of devices). Progress from the International Medical Device Regulators Forum (IMDRF) ..

As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4)  of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)  certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..

1. Foreword 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 patie..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: EU AIA and its inter play with the EU MDR/IVDR▶ 일시: 2025년 03월 20일 CST 9시 (한국시간: 03월 20일 23시)  The European Union issued the Artificial Intelligence Act (AIA), published as Regulation (EU) 2024/1689 in the Official Journal of the European Union on July 12, 2024. The regulation places additional requirements on manufacturers of AI-enabled devices. Medical device ma..

The European Commission (EC) opened a four-week consultation on draft legislation allowing electronic Instructions for Use (eIFU) for medical devices used by professional users. Here’s what medical device manufacturers need to know about the proposed legislation.Implementing Regulation 2021/2226 was intended to generally continue to advance Regulation 207/2012 on eIFU as devices (Article 3) that..

Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date, with five updated Q&As, two replacement Q&As, and one new Q&A. Of particular interest in this update, Question I.6 (Q I.6) concerns whether notified bodies would be able to..

2025 Commission Work Program The European Commission (EC) shared its priorities for 2025 (February 11, 2025). A press release accompanied the announcement, fact sheet and formal communication (COM(2025) 45 final), as well as the corresponding ANNEXES 1 to 5.The primary message: “Moving forward together: A Bolder, Simpler, Faster Union”.The communication describes the actions the EC intends to pr..