Posted 16 Might 2022 | By
The European Fee final week up to date its record of formally acknowledged harmonized requirements for in vitro diagnostics with a purpose to fulfill conformity necessities below the In Vitro Diagnostic Medical Units Regulation (IVDR).
The Fee has now formally added the worldwide threat administration normal EN ISO 14971:2019 to its reference record, in addition to an modification to the usual, EN ISO 14971:2019/A11:2021.
In complete, the Fee has acknowledged 10 harmonized requirements that may be referenced by check makers to fulfill conformity necessities. The beforehand acknowledged harmonized requirements relate to sterilization, aseptic processing, high quality administration techniques, the usage of symbols, and metrological traceability
Along with recognizing ISO 14971:2019, the Fee additionally revised its entry for the standard administration techniques normal ISO 13485 within the context of the IVDR so as to add the corrigendum to that normal, EN ISO 13485:2016/AC:2018, which “corrects solely formal facets of the European foreword and of the informative annexes, with out affecting the substance of the harmonised normal.”
The replace comes a number of months after the Fee posted a second batch of formally acknowledged harmonized requirements, and simply days earlier than the IVDR’s date of utility later this month. (RELATED: IVDR: Fee proposes to delay implementation amid ‘grave’ notified physique scarcity, Regulatory Focus 14 October 2021; IVDR: European Fee publishes second batch of harmonized requirements, Regulatory Focus 11 January 2022)
EUR-Lex
The Fee has now formally added the worldwide threat administration normal EN ISO 14971:2019 to its reference record, in addition to an modification to the usual, EN ISO 14971:2019/A11:2021.
In complete, the Fee has acknowledged 10 harmonized requirements that may be referenced by check makers to fulfill conformity necessities. The beforehand acknowledged harmonized requirements relate to sterilization, aseptic processing, high quality administration techniques, the usage of symbols, and metrological traceability
Along with recognizing ISO 14971:2019, the Fee additionally revised its entry for the standard administration techniques normal ISO 13485 within the context of the IVDR so as to add the corrigendum to that normal, EN ISO 13485:2016/AC:2018, which “corrects solely formal facets of the European foreword and of the informative annexes, with out affecting the substance of the harmonised normal.”
The replace comes a number of months after the Fee posted a second batch of formally acknowledged harmonized requirements, and simply days earlier than the IVDR’s date of utility later this month. (RELATED: IVDR: Fee proposes to delay implementation amid ‘grave’ notified physique scarcity, Regulatory Focus 14 October 2021; IVDR: European Fee publishes second batch of harmonized requirements, Regulatory Focus 11 January 2022)
EUR-Lex
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