To add to Dan's discussion, the requirements in EN ISO 14971:2012 are IDENTICAL (Clauses 1-9) to ISO 14971:2007. The Annex's ZA-ZB-ZC are only informative in nature indicating that CEN feels that the international version of the ISO standard does not meet the requirements of the three directives and that manufacturers need to take actions to meet those requirements. It is important to note that EN ISO 14971:2012 is not Harmonized to the new Medical Device Regulations (MDR) (or the IVDR). The Harmonization process for the new regulations has not been established nor personnel assigned. The draft of the new edition ISO DIS 14971 contains placeholder annexes for harmonization of the Standard. It is important to note the MDR and IVDR have highlighted errors that the 2012 document has, such as the use of IFU to reduce risk.
FDA recognizes US and international standards and not standards of other countries or regions written for the requirements of those other regions. It is not widely understood that EN standards such as EN ISO 14971:2012 only apply in Europe and only contain additional Informative Annexes and not additional or different requirements.
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Edwin Bills RAC, MA
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 21-Aug-2018 17:36
From: Dan O'Leary
Subject: ISO 14971:2007 vs. EN ISO 14971:2012
EN ISO 14971:2012 is an EU standard with three annexes that point out ways in which each of the three directives has more stringent requirements than the ISO 14971:2007. The good news is that if you comply with one of the versions of EN ISO 14971:2012, then you will also comply with ISO 14971:2007. As a result, EN ISO 14971:2012 has become the de facto global standard.
FDA people have a good understanding of the relationship. In my words, they don't care if you want to do extra work.
On another point, ISO 14971:2007 is not a regulatory requirement; it is a recognized consensus standard. You may choose to use it.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 21-Aug-2018 16:18
From: Anonymous Member
Subject: ISO 14971:2007 vs. EN ISO 14971:2012
This message was posted by a user wishing to remain anonymous
Point of clarification please that I can share with our Quality folks:
Isn't aligning to ISO 14971:2007 expected by the FDA for our risk assessment for the 510(k) submission of our IVD that will be marketed in the US? Isn't EN ISO 14971:2012 only for devices that at marketed in the EU?
thank you!