Virtually overnight, namely from 31.08.2012 to 01.09.2012 the ISO 14971: 2012 was published without a transition period as a harmonized standard for risk management for medical devices. This article introduces you to these changes.
One of the main innovations of ISO 14971 in 2012 (ISO 14971: 2012) was the requirement that all general risks must be minimized as far as possible, so there are no acceptable risks, per se.
The clarifications and additions in the informative (!) Annex ZA were written partly as a reinterpretation. Let's explore the various sub-chapters of this Annex:
The e-learning library shows you over 15 video exercise step by step, how you can create a lean and ISO 14971:2012 compliant risk management file.
Harmonized standards are designed to give manufacturers specific evidence, whether they comply with requirements of the EU directives. A manufacturer meeting these standards, is supposed to fulfill the requirements of the directives as well.
The main concern - perhaps even the only relevant one - is that medical devices must have an acceptable risk / benefit ratio. That means that the products actually help the patient and at the same time, the side effects have to be reduced as far as possible.
The ALARP area of risk management is defined as the area, in which risks must be reduced "as low as reasonably practical" (ALARP). But this "as far as possible" reference is understood in the ISO 14971 a little differently from the MDD - at least in the formulation they are not entirely clear. Each risk should be reduced "as far as possible" and not "as low as reasonably practical". What does "practical" mean? As far, until they have no more interest? So far, that one would have to design a new device? As far, until there is no more time or money?
In practice this has much to do with economic considerations that should be ignored in risk management. One consequence could be to simply abolish this ALARP region. Another is to establish for each ALARP risk, which is why a reduction is not reasonably possible. So rather an "as low as reasonably possible". This is how we manage it with our customers the whole time.
But what do you do when it turns out that a standard is no longer appropriate to maintain this assumption? For example, because it addresses the requirements of the directives incompletely or even wrong? You have several options:
For a short time, de-harmonizing (!) the ISO 14971 was apparently discussed. Now, they picked the third option and complement an appendix. The authors of ISO 14971 are running out of letters for the annex we have now arrived at ZA. There is no shortage of ideas. Because the 2012 edition differs from its predecessors, it’s in a class of its own.
If you have questions for the practical implementation of the ISO 14971:2012, and have the new features, then use the free audit consulting.