2019 Version of ISO 14971

The 3rd Edition of the Medical Device Risk Management standard, ISO 14971:2019, was approved May 2019 and replaces the second edition (ISO 14971:2007).

Key Changes Include:

  • Additional requirements of the Risk Management Plan.
  • Clarification to reasonably foreseeable misuse considerations.
  • Addition of a requirement for hazardous situations to be considered and documented.
  • Addition of a requirement for disclosure of residual risks.
  • Clarification to information collection requirements in production and post-production

For discussion on each of the changes, check out our full article.

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