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Harmonized standards up to date in March 2024


CSDmed recognize the crucial importance of staying informed about harmonized standards, which play a fundamental role in ensuring the conformity of medical devices within the European Union. While the official EU website provides a consolidated version of these standards updated until 2023, we are pleased to make available an updated extension including the most recent changes and additions since March 2024.

What are Harmonized Standards for?

Harmonized standards establish safety, quality and performance requirements that medical devices must meet to be considered compliant with European regulation MDR 2017/745. Compliance with these standards provides a “presumption of conformity” with legal requirements, thereby simplifying certification processes for manufacturers and enhancing protection for patients and end users.

The harmonized standards have an annex (Annex Z) which compares the requirements of MDR 2017/745 and how the standard meets them. The correspondence between the standard and the requirements is rarely exhaustive, which will be emphasized by phrases like “partially covered”.

Certain harmonized standards are applicable regardless of the medical device (EN ISO 14971/A11, EN 62366-1/A11, etc.) while others are applicable or partially applicable depending on the class and/or nature of the device. medical device (EN ISO 13485/A11, EN 62304/A1, EN 60601-1/A1, etc.)

Why Consult Our Consolidated List?

  • Timelineless: Get a comprehensive, up-to-date view, including 2024 Latest Amendment standards, ensuring access to the most up-to-date information.
  • Reliability: Our compilation is carefully checked by specialists in European regulations and standardization.
  • Accessibility: Easily access the list in a single table, designed to simplify your searches.
  • Indispensable resource: Essential for certification and guarantee of product conformity, our list is a valuable tool for your business.

Stay Informed and Compliant

In a constantly evolving regulatory environment, access to current and accurate information is key. With our consolidated list of harmonized standards, rest assured you have the knowledge necessary to navigate the European Union regulatory framework with confidence and accuracy. Explore our consolidated list now and ensure your business is fully prepared to meet the regulatory requirements of tomorrow.

List of up-to-date harmonized standards

Standard Reference document
EN ISO 10993-23:2021 EU 2021-1182
EN ISO 11135:2014/A1:2019 EU 2021-1182
EN ISO 11137-1:2015/A2:2019 EU 2021-1182
EN ISO 11737-2:2020 EU 2021-1182
EN IEC 60601-2-83:2020/A11:2021 EU 2022-006
EN ISO 10993-12:2021 EU 2022-006
EN ISO 10993-9:2021 EU 2022-006
EN ISO 11737-1:2018/A1:2021 EU 2022-006
EN ISO 13408-6:2021 EU 2022-006
EN ISO 13485:2016/A11:2021 EU 2022-006
EN ISO 14160:2021 EU 2022-006
EN ISO 15223-1:2021 EU 2022-006
EN ISO 17664-1:2021 EU 2022-006
EN 285:2015+A1:2021 EU 2022-757
EN ISO 14971:2019/A11:2021 EU 2022-757
EN ISO 10993-10:2023 EU 2023-410
EN ISO 25424:2019/A1:2022 EU 2023-410
EN 455-3:2023 EU 2024-815
EN ISO 10993-15:2023 EU 2024-815
EN ISO 10993-17:2023 EU 2024-815
EN ISO 10993-18:2020/A1:2023 EU 2024-815
EN ISO 11137-2:2015/A1:2023 EU 2024-815
EN ISO 11607-1:2020/A1:2023 EU 2024-815
EN ISO 11607-2:2020/A1:2023 EU 2024-815
EN ISO 17664-2:2023 EU 2024-815

We are at your service

European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety

🔗 Contact us and find out how we can help you.