Published on:
27. July 2022

Customer information on DIN EN ISO 13485:2021-12

Dear Sir or Madam,

in December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN ISO 13485. The standard DIN EN ISO 13485:2021 contains requirements for a quality management system for use by organisations that are required to demonstrate their ability to provide medical devices and related services – with the aim of continuously meeting applicable regulatory requirements and customer requirements.

Following the entry into force of Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices respectively, it was necessary to replace the European Annexes Z of EN ISO 13485, which represented the relationship between sections of the standard and EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC respectively.
Annexes Z have been redrafted on the basis of the current EU regulations on medical devices and in vitro diagnostic medical devices, respectively, so that the relationship between sections of the standard and Regulations (EU) 2017/745 and 2017/746 is now presented.

Implementing Decisions (EU) 2022/6 and 2022/15 of 4 and 6 January 2022 respectively harmonised the new version of the standard for Regulations (EU) 2017/45 and 2017/746.

In addition to the amendment of the (informative) Annexes Z, corrections and editorial revisions were included; however, there were no normative changes to DIN EN ISO 13485:2021 compared to DIN EN ISO 13485:2016.

The standard DIN EN ISO 13485:2021 replaces DIN EN ISO 13485 Corrigendum 1:2017-07, DIN EN ISO 13485:2016-08.

The deadline for the conversion of certificates according to DIN EN ISO 13485:2016 to DIN EN ISO 13485:2021 is 26 May 2024.

For procedures with certificates according to DIN EN ISO 13485:2016, for which the term ends BEFORE 26.05.2024, the conversion to DIN EN ISO 13485:2021 takes place within the framework of the next re-certification.

For procedures with certificates according to DIN EN ISO 13485:2016, for which the term ends AFTER 26.05.2024, the changeover to DIN EN ISO 13485:2021 takes place within the framework of the next surveillance. You will receive the information on the changeover with the order confirmation for the next surveillance procedure. The certificate according to DIN EN ISO 13485:2021 will then be issued for the remaining term of the certificate according to DIN EN ISO 13485:2016.

The conversion to DIN EN ISO 13485:2021 within the scope of surveillance audits begins for procedures with audit dates from 01.09.2022.

The conversion within the scope of a surveillance audit for certificates with a limited term until 26.05.2024 or beyond is carried out for you as a customer at no extra charge; including the reissue of the certificate according to DIN EN ISO 13485:2021 (1 certificate).

With the issuance of the certificate according to DIN EN ISO 13485:2021, existing certificate translations – based on the certificate according to DIN EN ISO 13485:2016 – lose their basis and thus their validity. If you require translations based on the newly issued certificate, these are subject to a charge (current price lists).

Certificates according to DIN EN ISO 13485:2016 with a limited validity period until 26.05.2024 due to DAkkS requirements will also be converted during the next surveillance audit.

The requirements of the DAkkS and the background to the conversion can be found here:
https://www.dakks.de/de/aktuelle-meldung/din-veroeffentlicht-neue-norm-din-en-iso-13485-2021-12.html

Gabriele Meyer
Head of Certification Body QM Systems