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EU 64

[Emergo, UL] Article 16(4) MDR & IVDR Certification: What Medical Device Manufacturers Need to Know

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 ..

뉴스 보고서 09:00:16

[EU] Update - MDCG 2020-16 rev.4 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)

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..

유럽 MDR, IVDR 2025.03.31

[Emergo, UL] Webinar: EU AIA and its interplay with the EU MDR/IVDR

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..

뉴스 보고서 2025.03.13

[Emergo, UL] EU Opens Consultation on Draft Legislation for Electronic IFUs

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..

뉴스 보고서 2025.03.11

[Emergo, UL] EU Revises Guidance on Notified Bodies: Structured Dialogues and Leveraging Evidence

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..

뉴스 보고서 2025.02.21

[Emergo, UL] Making the European Medical Device Nomenclature (EMDN) complete

What is the European Medical Device Nomenclature?Recently we updated you on Regulation (EU) 2024/1860 and how this amendment introduces a new approach on mandatory use of certain EUDAMED modules. Currently, 3 modules are live and those modules are expected to become mandatory in the upcoming year. One of the modules is the UDI/Device module. This module requires manufacturers to register their d..

뉴스 보고서 2025.02.07

[EU, IVD] Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)

The IVD expert panel has provided new scientific advice on SARS-CoV-2. The advice highlights that while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.  This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746. Manufacturers are encouraged to assess h..

유럽 MDR, IVDR 2025.02.05

[Emergo, UL] MHRA Releases Suite of Guidance for New Post-Market Surveillance Regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15) in alignment with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. BackgroundAs Emergo by UL reported last month, the amendment introduces new and enhanced PMS requirements for manufacturer..

뉴스 보고서 2025.01.23

[Emergo, UL] Australian TGA Expands EU Transitional IVDR Arrangements for New Inclusion IVD Applications

Manufacturers applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG) now have more options to leverage to fulfill the Manufacturer Evidence requirement to support an application. As a result, manufacturers may leverage their EU CE Marking Certificate issued under the IVDD to fulfill the Manufacturer Evidence requirement until the dates listed below...

뉴스 보고서 2025.01.21
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