UNITED STATES

New CLSI Guideline EP47: Evaluation of Reagent Carryover Effects on Test Results

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.

CLSI Webinar: What's New in Method Evaluation?

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]

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EUROPEAN UNION

MDCG 2024-12: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams

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.

MDCG 2024-11: Guidance on Qualification of In Vitro Diagnostic Medical Devices

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.

Learn more about EU Medical Device Registration.

CHINA

Announcement: New Medical Device Industry Standards Issued by the State Food and Drug Administration

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.

Learn more about China Medical Device Registration & Approval.

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