How to integrate risk assessment of a medical device to a SOP for ISO 14155:2020

[bill.Kal]

hi community,

as you know iso 14155:2020 has introduced a risk-based approach to the conduct of clinical investigations of medical devices. Annex H of the ISO 14155 describes how to apply risk management iso 14971 in a clinical investigation.

here come a few questions though.

as we are developing new SOPs for the conduct of clinical investigations, we are puzzled about how to incorporate requirements 6.2.1, 6.2.2, and 6.2.3 and more specifically the following

1. The sponsor shall predefine or establish risk acceptability thresholds and trigger a risk assessment to determine whether actions are needed as soon as thresholds are reached or exceeded
2. Risk control measures should be considered at both the clinical quality management system level (e.g. standard operating procedures, computerized systems, personnel) and clinical investigation planning and conduct (e.g. clinical investigation design, data collection, informed consent process).

I'm reading section 6.2.2, which says: ''risks associated with the investigational device and its related clinical procedure shall be estimated in accordance with iso 14971 prior to design and clinical investigation''

Does this mean that
1. predefinition or establishment of risk acceptability thresholds will be part of the RM of the device and no thresholds are required for the actual CI? Or should we develop a new acceptability matrix for the CI?
2. same question for the risk control measures: isn't the input from the RM files of the device enough? Do we need to take additional aspects into account for the 14155 SOP?

thank you in advance for the feedback!

 

[Enternationalist]

A device used in clinical investigations is, in many cases, not a finished device. It may have greater risks in some areas. These risks can be addressed in the clinical investigation itself. Let's say that the GUI isn't finalized - maybe you provide a specific IFU for the clinical trial to make sure that the GUI can still be used.

In addition, clinical investigations are - more or less by definition - a place where you are going to be receiving new and important data regarding your device's safety and effectiveness. You are expecting to receive new risk-related information. This could be things like the device not working as well as it should be. For that reason, you need to have a system in place to decide when you need to intervene in the investigation, make changes, or take other actions.

It's not the same risk profile as putting a finished device into market. You are putting a device for which the risk information is incomplete into a controlled clinical situation. You both have more things that could go wrong and a greater ability to control them and mitigate them when they do. The RM material you are making here is about managing that particular situation, not the final market product.

How you do this depends on your product and your clinical investigation - this is something to run past your regulatory bodies. Personally, I would create a clinical investigation SOP that refers to your risk management SOP and just tells you what extra/different things you need to do on top of it.