Medical Device and UNI EN ISO 13485:2021

In September 2021, the EN ISO 13485:2016/A11 standard was published, which modifies the ISO 13485:2016 standard.
The modification consists in the introduction of two informative Annexes (ZA and ZB) which describe the relationships between the European standard (EN 13485) and Regulations (EU) 2017/745 and 2017/746, relating respectively to medical devices and medical devices in vitro diagnostics.
On 18.11.2021 UNI issued the UNI CEI EN ISO 13485:2021 standard, implementing the aforementioned changes and withdrawing the UNI CEI EN ISO 13485:2016 version.
The transitional period of coexistence of the two editions of the standard ended on 18 November 2023 and all the documentation of the company Quality System must refer to the new edition.
Verification of the update will be carried out during the first planned surveillance audit.

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