ISO 14971:2019 has just been published!
Written by John Lafferty.
(Read Time: 4 minutes)
The long-awaited publication of ISO 14971:2019 Medical devices – Application of risk management to medical devices has finally happened.
ISO 14971:2019 is now available
The new standard is now available for purchase from the normal standards publication websites such as www.iso.org
. ISO 14971:2007 has been withdrawn. Medical device manufacturers can expect the normal three year transition period for compliance with the new standard.
New clarifications in ISO 14971:2019
The new standard contains no new requirements for risk management but contains some useful clarifications such a definition of ‘Benefit’ for the first time. The new standard also refers to Cyber Risks for the first time. Most of the guidance formerly contained in ISO 14971:2007 has been moved to its companion document ISO TR 24971:20XX which has not yet been published.
CEN's Response to ISO 14971:2019
The new ISO 14971:2019 standard has been designed to align more closely with international and national medical devices regulations such as the EU MDR 2017/745 and EU IVD MDR 2017/746 and makes reference to terms such as “State of the Art” (including a definition) and “As far as possible (AFAP)”. However, CEN has given the new standard a negative response and consequently, ISO 14971:2019 had been published with the usual Z Annexes which normally document the standard’s relationship to the EU directives and regulations. Also, there is no date for the publication of an EN version of the standard as, due to procedural delays related to the new EU MDRs, CEN is not in a position to publish EN standards at this time.
Outstanding Questions about ISO 14971:2019
All of this now this leaves us with three major questions;
1. Which standard will be accepted for compliance with the EU MDRs?
a.EN ISO 14971:2012 (for which the based standard ISO 14971:2007 had been withdrawn) or
b.A future EN standard based on ISO 14971:2019 (EN ISO 14971:20XX for which there is currently no publication date)
2. How to apply the new standard ISO 14971:2019 without the availability of the associated guidance document ISO TR 24971:20XX?
3. When will the EN standard EN ISO 14971:20XX and the guidance document ISO TR 24971:20XX be published?
The good news is, at least we now have one question less with the publication of ISO 14971:2019.
Ongoing updates on ISO 14971:2019
Training Course on ISO 14971:2019
Northridge Quality & Validation have planned a comprehensive training course; Quality Risk Management and ISO 14971 which will run on 25th March 2020 in the Clayton Dublin Airport Hotel, Dublin, Ireland. Course booking details can be found on www.sqt-training.com
By 25th March 2020 definitive answers to the above questions should be known.
ISO 14971:2019 Course - Summary of Course Content
The tutor John Lafferty of Northridge Quality & Validation will take attendees through the implications of the new ISO 14971: 2019 standard and the associated guidance document ISO TR 24971. Course attendees will also receive practical tips on how best to implement the new standard.
I look forward to meeting interested risk management professionals in the Clayton Dublin Airport Hotel on 25th March 2020, save the date.
About the Author - John Lafferty
John Lafferty is the owner of the Northridge Quality & Validation which provides consultancy to the Medical Device industry.
His specialities include Software Validation, MDSAP, ISO 13485, ISO 14971 and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education, Certificate in Quality Management.
He has over 25 years’ experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe.
SQT Training Tutor