New Harmonized Standards Published Under the MDR/IVDR
15 October 2024
MDCG 2021-25 Revised: MDR Requirements Applicable to MDD/AIMDD Legacy Devices
17 October 2024Table of Contents
New Open Consultation
As previously advised, the IMDRF Adverse Event Terminology Working Group has opened a new consultation: HERE
The purpose of the new guidance document is to “provide further guidance on the correct application and consistent use of the terminology”.
It will provide both general coding principles and examples of common coding difficulties.
Logistics
- The consultation is open until Monday 9 December 2024
- A word template is included for stakeholder comments
- Responses should be sent to the following contacts:
- Nancy A. Pressly, Food and Drug Administration (FDA), United States of America: [email protected]
- Andrea Hanson, Health Products Regulatory Authority (HPRA), Ireland, European Union: [email protected]
- Graham Nash (Maintenance Chair), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom: [email protected]
- Note that the e-mail subject line should state: Public Consultation on “Considerations for the Selection of IMDRF Adverse Event Terminology”
Webinar: 24 October 2024
The IMDRF Adverse Event Terminology Working Group and the MHRA will host a virtual webinar to discuss the above document.
The webinar will cover the following topics:
- An overview of the structure and layout of the document
- A reminder of the principles that form the foundation of the coding system
- Specific considerations for specific term selection
- Q&A
Logistics
- It is scheduled for Thursday 24 October 2024, from 3-4pm BST
- Note that registration will close on Monday 21 October 2024
- All stakeholders involved in the drafting and submission of adverse event reports are invited to join
- There is no fee to attend
- The link to sign-up is: HERE
