Regulation 2024/1860 Published: IVDR Extension, EUDAMED Rollout & Reporting Device Shortages
9 July 2024
EU Commission Publishes Updated Draft EUDAMED Timeline
12 July 2024Table of Contents
The MDCG published a new revision (Rev.3) to Guidance 2020-16 – IVDR classification rules, on 8 July 2024. It is available here.
Overview
The guidance was updated to reflect:
- Monkey Pox as a new indication Rule 3(a), as Class C (page 16)
- Further explanation on tests self-administered by lay persons and specimen containers (page 37)
- Additional indications under Rule 4(a), e.g., devices intended to measure the levels of calprotectin (page 38)
- Further explanation on specimen containers under Rule 5(c) (page 41)
- Add definition of a kit (page 4)
- Other more minor wording changes
Examples of Changes
Please see images below of some of the changes made (click images to enlarge).
Changes to rule 4 (page 37)
Changes to rule 5(c) (page 41) – further changes continued on following page of updated guidance
Further Reading
You may also be interested in the following topics:
- Links to Regulations & Guidance (kept current)
- List of Harmonized Standards and Common Specifications
- Steps to CE Mark to the IVDR
