Current List of Harmonized Standards under the EU-IVDR (In Vitro Diagnostic Devices)

Arlette Schilter
1 day ago
1 min read

This overview presents the currently harmonized and relevant standards for in vitro diagnostic devices (IVDs) under the European Regulation (EU) 2017/746 (IVDR).

Harmonized standards bridge the gap between legal requirements and technical implementation. They help demonstrate the state of the art and simplify the process of proving conformity with the IVDR.

All official Publications of EU-IVDR Harmonized Standards for invitro diagnostic devices (IVDs)

Current Status: 09.10.2024

Current List of of EU-IVDR Harmonized Standards

The current harmonization status is at 33.3%

✅ 15 out of 45 standards.

So please also check the IVDD harmonized standard list.

Table Structure

The table below provides all currently relevant standards, including the following information:

Reference & Title: Official designation and standard number
European Amendment: Reference to European amendments and corresponding national publications (e.g., SNV editions)
Comment / Harmonization: Status of harmonization and key application notes

Practical Recommendations

Regularly verify the latest harmonized versions in the Official Journal of the EU.
Note that non-harmonized international standards can still be used to demonstrate the state of the art if they fulfill applicable regulatory requirements.

Conclusion

Maintaining and updating your list of harmonized standards is essential for sustained compliance under the IVDR.A systematic approach to standards management accelerates development timelines, reduces audit risks, and ensures efficient market access.