Our first round-up of October 2024 medical device regulatory updates includes new CLSI guidelines and an upcoming webinar in the US, new MDCG guidance documents in Europe, and new industry standards from the NMPA in China.
The Clinical and Laboratory Standards Institute (CLSI) has released the first edition of EP47, Evaluation of Reagent Carryover Effects on Test Results. Published on September 11, this document offers detailed guidance for developers and laboratories on how to assess and mitigate reagent carryover during in vitro diagnostic tests. EP47 aims to standardize the evaluation process across the industry, helping ensure accurate and reliable test results by addressing potential carryover risks.
Join the webinar hosted by the Clinical and Laboratory Standards Institute (CLSI), which is highlighting the latest method evaluation standards. This session will feature discussions on the framework of CLSI EP standards, an overview of EP10 for quantitative medical laboratory procedures, and a preview of the newly released EP47 guideline on reagent carryover.
Date: November 12, 2024
Time: 1:00 PM ET
Speakers:
- Mark Kellogg, PhD, MT(ASCP), DABCC (Moderator)
- Paula Ladwig, MS, MLS(ASCP)
- Michelle Campbell, MS, MLS(ASCP)CMMBCM, SCCM
- Marvin Berman, PhD
- Tabitha Kern, MS, MLS(ASCP)CM
Link to Register: [CLSI Webinar: What's New in Method Evaluation]
Published by the EU Directorate-General for Health and Food Safety on October 7, 2024, this guidance document provides essential instructions for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and joint assessment teams (JATs) involved in MDR and IVDR regulations. It covers the establishment and review of corrective and preventive action (CAPA) plans to address non-compliances found during joint assessments, aiming to streamline the review process with structured templates for effective communication.
Published by the EU Directorate-General for Health and Food Safety in October 2024, this guidance document clarifies the qualification criteria for products under Regulation 2017/746 (IVDR). It defines the scope of in vitro diagnostic medical devices (IVDs) and their accessories, focusing on the distinction between IVDR and MDR regulations. The guidance includes examples of IVDs and accessories, offering manufacturers a framework for determining product qualification based on intended purpose, with reference to relevant European Commission resources.
On October 8, 2024, the National Medical Products Administration of China announced (link in Chinese) the approval of 34 medical device industry standards, including YY 0271.2-2024, titled "Dentistry Water-based Cement Part 2: Resin-Modified Cement." This announcement includes details on the standard numbers, names, scope of application, and implementation dates, which are available in the attached Medical Device Industry Standard Information Table. For more information, please refer to the annex provided.
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