---
title: "New MDCG Guidance Documents Released: Key Updates and Insights"
description: "On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. These forms will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment."
url: https://qbdgroup.com/zh-cn/regulatory-updates/new-mdcg-guidance-documents-released-key-updates-and-insights
type: "Regulatory update"
language: zh-cn
published: 2024-05-27
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "MDCG"
publisher: "QbD Group"
citation: "QbD Group, \"New MDCG Guidance Documents Released: Key Updates and Insights\", https://qbdgroup.com/zh-cn/regulatory-updates/new-mdcg-guidance-documents-released-key-updates-and-insights"
---
# New MDCG Guidance Documents Released: Key Updates and Insights
> On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. These forms will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment.

Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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##### On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.

- [MDCG 2024-6 preliminary re-assessment review (PRAR) template under Regulation (EU) MDR 2017/745](https://qbdgroup.com/hubfs/mdcg_2024-6_en_0.docx)
- [MDCG 2024-7 preliminary assessment review (PAR) template under Regulation (EU) MDR 2017/745](https://qbdgroup.com/hubfs/mdcg_2024-7_en_0.docx)
- [MDCG 2024-8 preliminary re-assessment review (PAR) template under  Regulation (EU) IVDR 2017/746](https://qbdgroup.com/hubfs/mdcg_2024-8_en_0.docx)
- [MDCG 2024-9 preliminary re-assessment review (PRAR) template under Regulation (EU) IVDR 2017/746](https://qbdgroup.com/hubfs/mdcg_2024-9_en_0.docx)

These form will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment.

## What does this mean to you?

MDCG 2024-6/7/8 and 9 are of relevance for the designation of Notified Bodies under MDR and IVDR.

[![Regulatory Affairs](https://no-cache.hubspot.com/cta/default/7030766/interactive-182180411307.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKPTkqO1BsP2IMNcRrffNo3FIRw45YYXVbUFAcoqR%2BjVJXruQ5CVd4TUjIs%2F%2FW%2FhFp%2BoOHK%2BhtZEdok9h8S1HtOVY8XvYleHj%2B3uhYPlBNgXbLjg5U1lv4XF6V6TTtULWrOaUwYnxodEYOJGCZoVOBXlIr5mWGWHyW57Y6u1pOHs%2BLV91iD8wW%2B7hYGxqiG%2FiixvUumEuug&webInteractiveContentId=182180411307&portalId=7030766)
## with ease.
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Source: https://qbdgroup.com/zh-cn/regulatory-updates/new-mdcg-guidance-documents-released-key-updates-and-insights — © QbD Group. Quote freely with attribution and a link back.