ISO 13485 · Medium · 13 min lesson
Risk control, residual risk, the risk management file and production and post-production feedback
ISO 14971:2019 clauses 4.5 and 7 to 10, ISO 13485:2016 clauses 8.2.1 and 8.2.2, EU MDR Annex I sections 2 and 4, Article 83
What you will learn
- Choose risk controls in the priority order of clause 7.1 and verify their implementation and effectiveness.
- Evaluate residual risk, benefit-risk and overall residual risk and describe the review before release.
- Maintain the risk management file and run production and post-production activities that update it.
Key takeaways
- Risk controls follow a priority order: inherently safe design, protective measures, then information for safety (clause 7.1; MDR Annex I section 4).
- Verify both that each control was implemented and that it is effective (clause 7.2).
- Evaluate residual risk, check controls for new risks (7.3, 7.5), use benefit-risk only when further control is not practicable (7.4), and judge overall residual risk (8).
- Review before release confirms plan implementation, acceptable overall risk and post-production methods (clause 9); the file keeps traceability (4.5).
- Production and post-production information is collected, reviewed and acted on, feeding the file (clause 10; ISO 13485 8.2.1, 8.2.2; MDR Article 83).
Free practice question
For the Pulsar P2 free flow risk, Halden considers three controls: a sentence in the manual, an audible alarm when the latch opens, and a mechanical lock that prevents the latch opening while the driver moves. All three are technically feasible.
Which should be the main control under clause 7.1?
The mechanical lock, because inherently safe design ranks first.
Correct. Clause 7.1 ranks inherently safe design first and information for safety last, as MDR Annex I section 4 also requires.
The sentence in the manual, because it costs nothing.
Not quite. Cost does not set the order in clause 7.1, and information for safety is the weakest option.
The alarm only, because alarms are always enough.
Not quite. An alarm is a protective measure and ranks below inherent safety when the stronger option is feasible under clause 7.1.
Any of the three, because the standard sets no order.
Not quite. Clause 7.1 sets a priority order, and MDR Annex I section 4 repeats it.
Key terms
- risk control: Process in which decisions are made and measures implemented to reduce risks to, or maintain them within, specified levels (clause 7).
- residual risk: Risk remaining after risk control measures have been implemented.
- overall residual risk: The combined residual risk from all hazardous situations, evaluated under clause 8.
- benefit-risk analysis: Weighing the medical benefit against residual risk when further control is not practicable (clause 7.4).
- information for safety: Warnings, instructions and training used as the third and weakest control option (clause 7.1).
- inherently safe design: Eliminating a hazard or lowering risk by design so no user action is needed.
- risk management file: Records providing traceability from each hazard to analysis, evaluation, control and residual risk (clause 4.5).
- post-production information: Information from production, service, complaints, literature and the field reviewed under clause 10.
Official sources
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
- Starfish Medical: Medical device risk management and the change from ALARP to AFAP (ISO 14971:2019+A11:2021 and the MDR)
- Regulation (EU) 2017/745 on medical devices (EUR-Lex)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.