How to document updates to the Risk Management File including the Benefit/Risk Analysis

Documenting Updates to the RMF and Benefit/Risk Analysis Video

Obtaining your own copy of ISO/TR 24971:2020

ISO/TR 24971 is a technical report on the ISO Standard 14971 and is in the most recent date revision of 2020. Unfortunately purchasing this standard comes with licensing agreements that prevent us from sharing the document with students. That requires the individuals or organizations to purchase their own copies of this technical report. Below are some of the websites that the standard is available for sale at. The ISO website is always a safe bet for purchasing standards from ISO, but we have experienced that sometimes prices vary, and standard and technical reports may be available at a lower price from the Estonian Center for Standardization and Accreditation. Both websites are provided below for purchase and price comparisons. Standards and Technical Reports are available from other sources as well and Medical Device Academy is not affiliated with or receives compensation from any of them, we are providing the links below simply for reference and convenience.

(International Standards Organization) ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971

(Estonian Center for Standardization and Accreditation) CEN ISO/TR 24971:2020 Medical devices – Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

Regulatory and Standard Considerations for the Risk/Benefit Analysis

From ISO 14971:2019 the requirement for a benefit-risk analysis is outlined within sub-clause 7.4 Benefit-Risk Analysis. This standard allows for a benefit-risk analysis to be conducted when a residual risk is not acceptable and additional risk control are not practicable. The purpose of this analysis is to determine if the benefits of the devices intended use outweigh the residual risk. This is from the standard and regulations from authorities having jurisdiction may require a benefit-risk analysis outside of those conditions.

Regulation (EU) 2017/745 under Article 83, Post-Market Surveillance System of the Manufacturer outlines that one of the purposes of the PMS System is specifically to gather data to update the benefit-risk analysis. Annex II, Technical Documentation under section 5. Benefit-Risk Analysis and Risk Management requires a benefit-risk analysis as part of your technical documentation. In fact, the benefit-risk analysis is part of Sections 1. and 8. of the General Safety and Performance Requirements of Annex I.

Similar if not potentially more strict requirements for a benefit-risk analysis can be found for IVDs within Regulation (EU) 2017/746. In particular, under Annex III, Technical Documentation on Post-Market Surveillance, Section 1(b) requires the following to be part of your PMS Plan;

“suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;”

And in Canada, the updates to the Canadian Medical Device Regulations will also require one for summary reports and reporting changes to the risks and benefits of a device.

In short, even though the standard may only require a benefit-risk analysis in certain circumstances the regulatory authority of the market may require one from you anyway.

Guidance on Summary Reports and Issue-Related Analyses for Medical Devices

Regulation (EU) 2017/745

Regulation (EU) 2017/746

FDA Guidance Documents

The FDA also has numerous guidance documents finalized for benefit-risk analyses. Some of them have been linked below, but the full amount can be found on the FDA searchable database.

FDA Guidance Document Searchable Databasehttps://www.fda.gov/regulatory-information/search-fda-guidance-documents

FDA Guidance factors to consider regarding benefit-risk in medical device product availability compliance and enforcement decisions

FDA Guidance Factors to Consider When Making Benefit-Risk Determinations for Medical Device investigational Device Exemptions

FDA Guidance Benefit-Risk Factors to Consider when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics

FDA Guidance factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications

FDA Guidance consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals de novo classifications and humanitarian device exemptions