Harmonized standard medical devices and IVDs
Process standards
Note: The harmonization of norms regarding the regulations MDR and IVDR is still ongoing. Therefore, this list is not exhaustive and may change over time. It is recommended to keep up-to-date with the official websites of relevant standardization bodies and notified bodies to obtain the most current information.
Most of the european harmonized standards for medical devices are also mentioned by other international authorities. See here for information.
Benefit of applying standards
ColabON: Access to all data at clause level
With ColabON, you gain access to all relevant norms and regulations for the medical device / in vitro diagnostic industry in a structured and easily understandable format. The data is provided at clause level, enabling you to conduct precise and detailed analysis.
CEN Reference Standard Number, and SNV Reference | Standard Title | MDR harm. Date IVDR harm. Date |
|---|---|---|
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | OJ L 138 – 17/05/2022 OJ L 135 –12/05/2022, incl. A11 corresponce of to IVDR/MDR ready to use. | |
EN ISO 14155:2011+AC:2011 | Clinical investigation of medical devices for human subjects – Good clinical practice | not harmonized yet, new version published  ISO 14155:2020 |
EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) | OJ L 138 – 17/05/2022, OJ L 135 – 12/05/2022, ready to use. Recommended together with ISO/IEC Guide 63 and ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management. Incl. Amendment A11with IVDR/MDR correspondence. |
n/a | Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971) | not on the harmonization plan, but essential for the application of ISO 14971:2019 Already in ColabON |
EN IEC 62304:2006+A1:2015 CSV | Medical device software – Software life-cycle processes | not harmonized yet, but in ColabON |
EN IEC 62366-1:2015+AC:2016 CSV | Medical devices – Application of usability engineering to medical devices | not harmonized yet, but in ColabON |
In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916) | n/a | |
IEC 80001-1:2011 | Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management | not harmonized yet, new international standard published IEC 80001-1:2021 |
IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle (IEC 81001-5-1) | |
IEC 82304-1:2017 | Health Software – Part 1: General requirements for product safety | not harmonized yet, but ready to use ColabON. IEC 82304-1:2016 enlarges process requirements for healthcare software, e.g. software not being medical device or ivd |
The Standard Harmonization Plans
Mandate M/575 - C(2021)2406 : 2021-03-12
M/575 Amd 1 – C(2023)694
We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions.
Publications in the Official Journal
Get the current and planned harmonized standard list for medical devices and ivds