The turn of the decade isn’t going unnoticed when it comes to medical device standards. The long awaited Risk Management standard (ISO 14971, 3rd Ed.) was released for publication in late 2019. In addition, there is a new companion guidance document released, known as ISO/TR 24971:2019. Technical Reports (TR) are one of the types of documents that ISO publishes. A TR requires less international consensus than their Standards. Also, it is close enough numerically to be remembered as a companion, and not disassociated with ISO14971:2019.
At first glance it seems a loss that the well-used & familiar references (Annexes C, and F – J, see below) were stripped from ISO 14971, and another standard will need to be purchased in order to retain current references. However, by drilling past the surface information of this updated standard, a very logical gold mine of information is provided for us, that hasn’t been previously available.