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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..

Call for applicationsMember States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation (EU) 2017/745 (MDR) and 74 of the Regulation (EU) 2017/746 (IVDR) respectively. This pilot will allow sponsors to submit a single applica..

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..

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..

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..

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...

MDCG 2024-7 Rev.1MDCG 2024-7 Annex  mdcg_2024-7_en_0.docx https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F939cc0b8-8db5-4b0d-b2b7-a15a98a44cbd_en%3Ffilename%3Dmdcg_2024-7_en_0.docx&wdOrigin=BROWSELINK인터넷 홈에서 파일을 검색하는 동안 잠시 기다려 주세요.view.officeapps.live.com

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..

Introduction Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis. In accordance with these conformi..

When to expect the first modules of EUDAMED to become mandatoryBy Annette van RaamsdonkAfter several meetings, consultations and a draft version, the final version of the Questions and Answers (Q&A) on EUDAMED was published a few weeks ago, in November. The Q&A document is a guidance document giving practical information on the new requirements, which followed Amendment (EU) 2024/1860, which we ..