EU Guide: Unannounced Notified Body Audits of a Manufacturer and Its Suppliers
14 October 2024
IMDRF New Consultation & Webinar: ‘Considerations for the Selection of IMDRF Adverse Event Terminology’
16 October 2024Table of Contents
Overview
The following Casus resource has been updated accordingly: Consolidated List of EU MDR/IVDR Harmonized Standards & Common Specifications
Newly harmonized under the MDR
| Reference number of the standard | Title of the standard |
|---|---|
| EN ISO 13408-1:2024 | Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) |
Newly harmonized under the IVDR
| Reference number of the standard | Title of the standard |
|---|---|
| EN ISO 13408-1:2024 | Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) |
| EN ISO 20916:2024 | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) |
