IVDR: Commission adds risk management standard to harmonized standards list

Regulatory NewsRegulatory News | 16 May 2022 |  By 

The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The Commission has now officially added the international risk management standard EN ISO 14971:2019 to its reference list, as well as an amendment to the standard, EN ISO 14971:2019/A11:2021.
In total, the Commission has recognized 10 harmonized standards that can be referenced by test makers to satisfy conformity requirements. The previously recognized harmonized standards relate to sterilization, aseptic processing, quality management systems, the use of symbols, and metrological traceability
In addition to recognizing ISO 14971:2019, the Commission also revised its entry for the quality management systems standard ISO 13485 in the context of the IVDR to add the corrigendum to that standard, EN ISO 13485:2016/AC:2018, which “corrects only formal aspects of the European foreword and of the informative annexes, without affecting the substance of the harmonised standard.”
The update comes several months after the Commission posted a second batch of officially recognized harmonized standards, and just days before the IVDR’s date of application later this month. (RELATED: IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage, Regulatory Focus 14 October 2021; IVDR: European Commission publishes second batch of harmonized standards, Regulatory Focus 11 January 2022)


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