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[EU] Preliminary assessment review (PAR) form template (MDR)

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

As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.Background on clinical investigations in BrazilSome medical devices are exempt from ANVISA approval of the study (RDC 837/2023, Article 2 (§ 1º)), including Class  I and II medical devices, IVD clinical performance studies, devices already registe..

SummaryOn December 4, 2024 the U.S Food and Drug Administration (FDA) held a Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps.During this town hall, we discussed two short topics, including the new Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices Guidance, and research and modeling on..

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate Artificial Intelligence and Machine Learning (AI/ML).  The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States (updated).  Artificial Intelligence and Machine Learning (AI/ML..

The medical device regulator in Canada, Health Canada (HC), has now made the clinical information provided in support of an application public and it can be accessed via HC’s portal. This may include the following information but not limited to the clinical summary, clinical data study protocols and reports, literature studies and Clinical Evaluation Reports.  Health Canada: Clinical Information..

Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of sof..

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 ..

Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design...

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..