ISO 13485:2016 significantly amended – Amendment 11 published Sep 2021

ISO 13485:2016 amendments can have significant effects on medical devices

An 'Informative' Amendment that must not be ignored

The ISO website currently shows the ISO 13485 standard as ‘confirmed’ in January 2020. So, no changes then to the standard itself and no alignment with the High-Level Structure (or Harmonized Structure). The next review is due in 2024; so a revised standard is unlikely before 2026.


ISO 13485 Amendment 11


However, there is another mechanism that can be used to ‘adjust’ the ISO 13485 Standard and that is exactly what we’ve got with EN ISO 13485:2016/A11 (published September 2021). Two new Annexes, which apply only to manufacturers selling medical devices in the EU Regulatory Area, provide a comparison of the requirements of ISO 13485 versus the requirements of EU Regulation, that is, they identify the gaps. The titles of the new Annexes are …


Annex ZA: Relationship of this (harmonized) European standard and the requirements of Regulation (EU) 2017/745 (MDR) aimed to be covered

Annex ZB: Relationship of this (harmonized) European standard and the requirements of Regulation (EU) 2017/746 (IVDR) aimed to be covered


Note1 1: we have added the words in brackets to clarify the otherwise poorly-worded titles.

Note 2: The previous Annexes, ZA, ZB and ZC, are of course now obsolete.



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Additional questions regarding regulatory compliance


Both ISO 13485 Annexes are marked ‘informative’ as opposed to ‘normative’ (mandatory). However, these Annexes must not be ignored. Their publication now clarifies where compliance with ISO 13485 requirements is not sufficient, or only partly sufficient, to meet EU regulatory requirements. This gives Notified Body and Certification Body Auditors a long checklist of authoritative questions that they can ask regarding regulatory compliance. Expect them to use this ‘checklist’.

Manufacturers of medical devices for the European market, and for the UK market pro temp, are strongly advised to review their Design & Development files (see Clause 7.3.10) against the relevant Annex and add documentary evidence to show how the regulatory ‘gaps’ have been adequately addressed.

A word of warning for manufacturers of self-certified CE Marked devices


Many self-certified manufacturers hold CE Mark Certificates of Conformity (CoC) with validity as far ahead as 2024. This is frequently, and incorrectly, interpreted as meaning that the MDR or IVDR do not apply to them until the CoC runs out. The exact situation is that the only derogation from the regulations is in relation to the self-certified CoC; otherwise, MDR and IVDR apply in full. And so, Amendment 11 will be relevant to these manufacturers as to all medical device manufacturers for the European market.

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Written by Dr John FitzGerald

Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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