The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle. It is pointed out explicitly though that the standard may also be applied to other products. Medical devices designed to facilitate decision making in the course of clinical processes or company risk management are not included in the standard´s objective. The standard may be used independently from existing quality management systems. Interestingly, the introduction contains notes on the auxiliaries "shall", "should", "may", "can", "must" and their interpretation in connection with the standard.

What is new?

The version of 2019 has 36 pages and regulates, amongst other things, the requirements for "residual risk", also with regard to implementation into a risk management plan. There are also several new definitions, i.a. for "benefit". Further, there are more details for requirements resulting from collected information regarding safety-relevant data. There is a new passage directed at the senior management detailing how a risk management policy is to be defined. The revision period for the version of 2019 is intended to be 5 years.

Source: www.gmp-compliance.org