---
title: "Newly Listed Harmonized Standards"
description: "On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union, adopting two new harmonized standards under Regulation (EU) 2017/746 (IVDR) and one under Regulation (EU) 2017/745 (MDR)."
url: https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-listed
type: "Regulatory update"
language: zh-cn
published: 2024-10-14
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Newly Listed Harmonized Standards\", https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-listed"
---
# Newly Listed Harmonized Standards
> On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union, adopting two new harmonized standards under Regulation (EU) 2017/746 (IVDR) and one under Regulation (EU) 2017/745 (MDR).

EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) is now a harmonised standard under both the MDR and the IVDR, whereas EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) is now a harmonised standard under the IVDR.

[Commission Implementing Decision (EU) 2024/2625 amending Implementing Decision (EU) 2021/1195](https://eur-lex.europa.eu/eli/dec_impl/2024/2625/oj)

[Commission Implementing Decision (EU) 2024/2631 amending Implementing Decision (EU) 2021/1182](https://eur-lex.europa.eu/eli/dec_impl/2024/2631/oj)

### What does it mean to you?

Compliance with standards ISO 13408-1:2023 or ISO 20916:2019, while not mandatory, now confers a presumption of conformity with the corresponding requirements set out in either the MDR or the IVDR.

[![CTA RA update](https://no-cache.hubspot.com/cta/default/7030766/interactive-184700193895.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLJ%2FWgrHFLZUhfnuyu23dJRQKXN4OJoAUeCEUwd2iUfInHAPYoKgK%2FNvaCsrX9m8%2B2Fap8bTqxTu06bJ8b5jfjLzm0rzKQtEom1IerF52sbNGtX0DnRFbTmecZ5YYt4fhybDZPqD1w%2BFjdHY%2F0IwLt74jVCOqxTPv07s1bbvu3Sm6eGhxSMsjgg%2FHucHjQ1lnzKzGgGN9E2fsDPbX3WG4O2Pew%3D%3D&webInteractiveContentId=184700193895&portalId=7030766)
---
Source: https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-listed — © QbD Group. Quote freely with attribution and a link back.