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Current List of Harmonised Process Standards MDR and IVDR


CEN Reference Standard Number


SNV Reference

Standard Title

MDR harm. Date

IVDR harm. Date

Comment

EN ISO 13485:2016,


EN ISO 13485:2016/A11:2021


EN ISO 13485:2016/AC:2020


SN EN ISO 13485:2016,


SN EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

OJ L 138 – 17/05/2022 OJ L 135 –

12/05/2022

Already in ColabON,



Corresponce of Amendment A11 entered with IVDR/MDR!



EN ISO 13485:2016/AC:2020 *for MDD and IVDD see for explanation

EN ISO 14155:2011+AC:2011 

Clinical investigation of medical devices for human subjects – Good clinical practice 

not harmonised 

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

Already in ColabON together with ISO/IEC Guide 63 and ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management



Corresponce of Amendment A11 entered with IVDR/MDR!



Already in ColabON

n/a

Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971)

n/a

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 harmonised 

Already in ColabON

EN IEC 62366-1:2015+AC:2016 CSV

Medical devices – Application of usability engineering to medical devices 

not harmonised 

Already in ColabON


In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916)

n/a

New standard


ISO 20916:2019

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 harmonised 

IEC 80001-1:2021


IEC publication date: 2021-09-21

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)

not harmonised 

IEC 81001-5-1:2021



Already in ColabON

IEC 82304-1:2017

Health Software – Part 1: General requirements for product safety

not harmonised 

IEC 82304-1:2016


IEC publication date: 2016-10



enlarges process requirements for healthcare software, e.g. software not being medical device or ivd



Already in ColabON

Harmonised standard list for process standards


Exploring the Harmonised Standards List MDR IVDR

Our objective with the Harmonised Standards List MDR IVDR is to provide you with an in-depth overview of both the current status and the anticipated future updates. We have meticulously curated this list by aligning it with the MDR and IVDR requirements and the Commission’s harmonisation plan. However, it’s important to note that the harmonised standards list is a work in progress, as elaborated below.



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



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