NSAI is happy to announce that the public enquiry draft of ISO 14971-Medical Devices- Application of Risk Management is now available on Your Standards Your Say, until the 12th of September. For Information on how to use “Your Standard Your Say, see: https://www.nsai.ie/standards/standards-commitees/your-standards-your-say/

The main changes in the draft of ISO DIS 14971 are:

  • Clause on normative references included
  • Terms are updated to include a definition on benefit and to align with the new ISO/IEC Guide 63
  • Greater focus on benefit-risk analysis and more attention given to the benefits that are expected from use of the medical device
  • Explained that process in the standard can be used for managing all types of risks associated with medical devices including those related to data and system security
  • Method for evaluation of overall residual risk and the criteria for acceptability must be defined in the risk management plan
  • Before commercial distribution a review of the execution of the risk management plan is completed and the results are documented as a risk management report. The manufacturer must determine when subsequent reviews and updates to the risk management plan are needed
  • Clarification on production and post-production information including details on the information to be collected and the actions taken when information is determined to be relevant to safety
  • Several informative annexes are moved to the guidance document ISO TR 24971 which is being developed in parallel
  • Annex B lists comparison between clauses of the 2nd edition and the proposed 3rd edition.

This revision work is being carried out by ISO Technical Committee TC 210 – Quality management and corresponding general aspects for medical devices. For more information on the current work programme of ISO TC 210 see the ISO website -https://www.iso.org/committee/54892/x/catalogue/p/0/u/1/w/0/d/0

NSAI can facilitate national experts getting involved in international standards work for the medical device sector. For more information see Healthcare standards or contact the national secretary, Linda Hendy on linda.hendy@nsai.ie