ISO 14971:2019 was published in December 2019. The changes in ISO 14971:2019 involve the addition of a number of 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 guidance document ISO TR 24971. Medical Device manufacturers are advised to use ISO TR 24971 in conjunction with ISO 14971:2019 as the basis of their Risk Management system. ISO 14971:2007 has been withdrawn and Medical Device manufacturers can expect the normal three-year transition period for compliance with the new standard.
ISO 14971:2019 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 and definition) and “As far as possible (AFAP)”. However, ISO 14971:2019 has been decoupled from the EU MDR harmonization process and was published without the usual Z Annexes. This means that EN ISO 14971:2012 still remains the appropriate standard for Risk Management for CE Marked Medical Devices.
The implications of the new standard and associated guidance and the changes required in order to achieve Risk Management compliance for EU and non-EU markets will be made plain by this informative one-day course on ISO 14971:2019. The course covers the regulations governing Risk Management for Medical Devices and the practical implementation of Risk Management from design, manufacture, distribution and use, through to post market feedback.Collapse
9:00am to 4:30pm
(includes course documentation).
The above question was posed by one of the delegates at a recent Quality Risk Management and ISO 14971:2019 virtual training course delivered by our expert Tuto...
“ISO 14971 is Changing’’ As many of you may know already, ISO 14971 is changing yet again! Changes to ISO 14971 The new standard will be known as I...