Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.
In 2016, a vote was conducted to reaffirm the ISO 14971:2007 standard; however, nearly 60 comments were submitted requesting more information on the implementation of the standard. This lead to a Technical Committee convening to work on updating the standard.
I recently attended a webinar hosted by Edwin Bills of GreenLight Guru. Bill was a part of the working group updating the ISO 14971 standard. This blog outlines a few of the changes in ISO 14971:2019 that we should expect in the near future.
ISO 14971 was revised as follows:
- The key concepts and core approach to risk management was maintained
- Clarification was added around the following:
- Production and post-production information
- Clinical benefits and risk-benefit analysis
- Update the guidance in the annexes
- Revise ISO TR 24971- The Technical Report that provides guidance on the application of ISO 14971
The final approach was that Informative Annexes would primarily reside in ISO TR 24971 because it is easier to update a Technical Report than it is a standard. A new Clause was added: Clause 2 on Normative References. As a result, all Clauses past Clause 1 are incremented by 1.
ISO 14971/TR 24971 Changes:
- Annex 1- risk analysis for biological hazards, was removed from ISO 14971 and moved to ISO 10993-1
- ISO 14971:2007 has 15 pages of requirements, whereas ISO 14971:2019 has 17 pages of requirements
- Roughly 2 pages of revised requirements (Clause 10: Production and Post-production Activities)
- ISO 14971:2007 has 70 pages of informative annexes, whereas ISO 14971:2019 has 35 pages of informative annexes
- ISO TR 24971:2013 has 16 pages of informative annexes, whereas ISO TR 24971:2019 has 102 pages of informative annexes
- Net result of 51 new pages of informative annexes
Clause 9 was retitled to Risk Management review to ensure that the risk management plan has been implemented, that the residual risk is acceptable and that there are appropriate methods in place to collect information in the post production phases. The reviewers must be identified in the plan and have the appropriate authority, and additional review may be needed after device distribution, once post production information is collected.
Clause 10 was retitled to Production and post-production activities. This section aligns heavily with Clause 8 (Measurement analysis and improvement) in ISO 13485. This clause emphasizes the need to actively gain information as opposed to waiting for complaints. This also aligns with post market surveillance.
While the Technical Report compliments the standard, it is important to note that the information in ISO TR 24971:2019 serves only as a guidance, and not requirements. As well, the first 3 annexes in ISO 14971:2019 act as guidance, and not requirements. The TR 24971:2019 has not been released yet.
Azra Rajwani is a StarFish Medical QA/RA Specialist. A graduate of the UVIC Biomedical Mechanical Engineering Program and former member of our biotechnology team, some of Azra’s work projects include water quality and neural networks.