What is ISO 14971?
ISO 14971:2019 is a standard for the application of risk management to medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.
What is the current ISO 14971 standard?
The third edition of the standard for application of risk management to medical devices – the ISO 14971:2019 – was published in December 2019 (along with the EN version), followed by the technical report ISO/TR 24971:2020 in June 2020.
The publishment of the new edition is a result of a vote taken by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2016. Reasons for the update included:
- lack of guidance on risk management,
- missing or outdated definitions, and
- the alignment with the requirements of ISO 13485, EU MDR/IVDR and FDA.
Will ISO 14971:2019 be harmonized with the EU legislation?
The expectation of the industry before the publishment of the EN ISO 14971:2019 was, that the new standard will also be harmonized with the EU legislation, therefore replacing the previous edition when the Regulations will replace the Directives. To this point in time that did not yet happen. It is clear that the new ISO 14971:2019 standard will not be harmonized with the current directives, but the harmonization with the MDR/IVDR is currently still unclear.
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Is EN ISO 14971:2012 still a valid harmonized standard?
When the EN version of the third edition was published, it specified in the European foreword that this standard shall be given the status of a national standard and conflicting national standards shall be withdrawn at the latest by June 2020. Consequently, the EN ISO 14971:2012 was withdrawn in June 2020, leaving many manufacturers in doubt if applying this harmonized standard as a presumption of conformity to the Essential Requirements of the EU Directives is still possible. The European Commission published that although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation and conformance with the regulation’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union. So, for the medical devices being certified under the current Directives, the EN ISO 14971:2012 is still a valid harmonized standard.
Is ISO 14971:2019 recognized by the FDA?
Yes, it is a recognized consensus standard by the FDA, together with the second edition, which will continue to be accepted till 25th December 2022.
Abbrevations connected to ISO standards
ISO – Organization for Standardization
IEC – International Electrotechnical Commission
FDA – Food and Drug Administration
EN – European Standard
MDR – Medical Device Regulation 2017/745
IVDR – In Vitro Diagnostic Medical Device Regulation 2017/746