Medical devices — Quality management systems — Requirements for regulatory purposes
Is the official title of the ISO standard 13485. EN ISO 13485 Amendment A11 2021 is the european addition. This amendment help sto show, conformity with the requirements of European Regulation.
When was ISO 13485 last updated / changed?
The international standard organization (ISO) published the latest international edition of ISO 13485 in 2016.
Amendment A11 is available as national standard. For Switzerland it is SN EN ISO 13485/A11:2021. All CENELEC member countries must publish the amendment unchanged.
The European Union has published EN ISO 13485/A11:2021 in 2021. EN standards aren’t available for purchase.
What is new in the Amendment EN ISO 13485 A11 2021?
In detail, the CENELEC added European foreword and the informative appendix ZA and ZB.
- New European foreword
- New informative Annex ZA pointing to (EU) 2017/745 MDR
- Correspondence between this European standard and Article 10
- Correspondence between this European standard and Annex IX
- New informative Annex ZB pointing to (EU) 2017/746 IVDR
- Correspondence between this European standard and Article 10
- Correspondence between this European standard and Annex IX
In standardization in general, one document after the other must be incorporated in order to have the correct final version. In this particular case, A11:2021 totally overwrites AC:2020. But keeps the text of ISO 13485:2016 as EN ISO 13485:2016 without any modification.
Harmonised standard information to EN ISO 13485 to MDR and IVDR
Add amendment EN ISO 1385 A11:2021 to the international edition of ISO 13485:2016.
AC:2020 and EN ISO 13485:2016 point to the old regulations of MDD and IVDD.
What is DIN EN ISO 13485:2021-12?
Beuth has published a German consolidation version of EN ISO 13485:2016 + AC:2018 + A11:2021.
Beuth adds the new date 2021-12 to the entire consolidated version of the publication. Sometimes, this introduces a bit of confusion.
However, it is helpful for the industry to have consolidated versions. Understanding the whole change of regulations and the corresponding harmonised standards isn’t straightforward.
Current and latest Versions of EN ISO 13485:2016 + AC:2020 + A11:2021
What is the Corrigendum SN EN ISO AC:2020 for?
https://connect.snv.ch/de/sn-en-iso-13485-ac-2020
Changes to European parts of EN ISO 13485:2016
This corrigendum changes the European foreword, and the informative European Appendixes ZA-ZC. In detail, this corrigendum incorporates the following corrections:
- Combination of EN ISO 13485:2016 and the corrigendum EN ISO 13485:2016/AC:2018. Which has superseded (replaced) EN ISO 13485:2012 and CEN ISO/TR 14969:2005.
- Changes to the informative Annex ZA. Where the correspondence to the amended 90/385/EEC on Active implantable medical devices (AIMD) is described.
- Changes to informative Annex ZB: Correspondence to the amended EU Directive 93/42/EEC on Medical devices (MDD).
- Changes to informative Annex ZC: Correspondence to EU Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD).
SNV publishes the three publications separately.
Why should I use harmonised standards?
Because if you’ve fulfilled the requirements of ISO 13485, you’re automatically covered some paragraphs of the MDR and IVDR. Where Amendment A11:2021 shows common requirements of ISO 13485 and the IVDR and MDR. As a result, the interpretation of the regulations become clearer.
The MDR and IVDR word it in their Article 8 the following way:
Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
MDR Article 8 Requirement 1
Lear more about harmonised standards here.
See the latest updates of the MDR and IVDR harmonised standard list.
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ColabON helps you with MDR, IVDR and ISO 13485 interpretation. We show the information of harmonised standards in the digital MDR and IVDR in one view. So you have more information and are quicker to implement MDR or IVDR. Furthermore, we can connect your QMS to the requirements to find gaps quickly.