Application of risk management to medical devices was developed specifically for manufacturers of medical devices or medical systems on the basis of established principles of risk management that have evolved over many years. The standards is known as ISO 14971.

As a general concept, activities in which an individual or an organization is involved can expose those or other stakeholders to hazards which can lead to a harm, i.e., injury or cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder can place a different value on the probability of harm occurring and its severity.

The author of ISO 14971 medical device risk management standard and its accompanying guidance document, ISO TR 24971, an ISO Technical Report is technical committee known as JWG1.

The group JWG1 falls under supervision of ISO Technical Management Board. In 2016, the ISO Technical Management Board directed JWG1 to revise both documents to address comments received during the voting process.

To current date , tha latest released draft version is ISO/DIS 14971:2018(E). What is important to the industry is the direction this update process is taking:

  • per ISO’s instructions, the aim is not to revise the risk management process, but rather to improve the information on implementation of the risk management process. So, companies with processes that currently conform to the standard should not have to make large revisions to their processes to comply with the new document, as it is presently being envisioned.
  • The revised standard appears simpler and easier-to-read, as many annexes were moved into the ISO/TR 24971. Specifically annex C is gone, which was missunderstood in many organisations as mandatory questionary list which need to be answered. With high probability current Annex E will become a revised Annex C in the new ISO 14971 document.
  • There are new definitions added to the standards, the most important is „benefit“. In this context overall risk-benefit present in standard is reinforced.

The new edition of ISO 14971 will continue to be an international standard and will not address national and regional issues. Those will be left up to the national and regional standards bodies as before. While EN ISO 14971:2012 is harmonized to the Medical Device Directives, it is not harmonized to the MDR which has benn released recently. A new CEN document will have to be created to address these differences, and that may not happen until the new ISO 14971:20XX is released. We can expect that similar situation can happen as it was with release of controversial Annex ZA of the EN ISO 14971:2012 standard.