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Legislative background on shortagesOn March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions discuss the notification of shortages to the regulator Health Canada. If an explicit device is delineated on the “List of Medical Devices- Notification of Shortages” and the manufacturer or import..

The technical document Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology and Codes has been updated by The International Medical Device Regulators Forum (IMDRF) Adverse Event Terminology working group (AET WG). The current update consists of 36 newly added terms, changes to 56 existing terms and the retirement of eight terms. Release notes that provide a high-level ..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

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..

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..

Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics:1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including mitigation of risk of shortages of in vitro diagnostic medical devices (IVDs) needed for the smooth functioning of healthcare service..

BackgroundAs noted in a previous Regulatory Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposed changes to the medical device regulatory framework in GB. This includes the introduction of a new framework that would allow certain medical devices authorized by other countries to be placed on the GB market without needing a UKCA (U.K. ..

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..

You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC. In addition, the Heads of Medicines Agencies (HMA, heads of EU Competent Authorities responsib..

Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months. Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMEDRegulation 2024/1860 was officially released to extend the transition time for legacy IVDs, roll out EUDAMED, and require data on di..