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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..

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..

1. Introduction Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report..

Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746)  This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745..

Introduction and scope The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR) aims to ensure an adequate level of identification and traceability with respect to medical devices. Basic UDI-DIs, UDI-DIs and UDIPIs shall be assigned (in compliance with the rules of the designated issuing entities) by manufac..

BackgroundFollowing the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medica..