How your Post Market Surveillance data can help you with the usability of your established medical device
Usability of medical devices is a hot topic
We have seen an increase in the number of long-standing devices undergoing technical file reviews. Notified Bodies are raising non-conformities for not addressing usability. Sound familiar? The prospect of conducting a usability study can be expensive and time-consuming. Resulting in manufacturers reaching out for guidance. So, today I wanted to share with you a solution that you may not be aware of.
ISO 62366 and UOUP (User Interface of Unknown Origin)
If you device was on the market prior to the standard being published, ISO 62366-1:2015 has the option for USER INTERFACES (or parts of) to be considered as UOUP (USER INTERFACE OF UNKNOWN ORIGIN). Instead of complying with all the requirements, you can evaluate your device according to Annex C. Those lovely people who wrote the standard were smart to understand this is meant to be used during the development stage. However, your device has already been developed. So, Annex C allows you to assess the usability of your device by reviewing your post market surveillance data. What you say! I know, good right.
But a word of caution – if any changes to your device’s USER INTERFACE or its parts have been made then they are subject to Clauses 5.1 – 5.8 of the standard. Only the unchanged parts of the USER INTERFACE remain in UOUP and can undergo this review.
Post Market Surveillance Data and Usability
So, Annex C asks you to establish a Use Specification and to review your post production data, including complaints and field reports for incidents or near incidents. Therefore, if you have been good at gathering your post market data, and let’s face it, that’s all Notified Bodies and other blog sites have been telling us to do in preparation for MDR, then you should have the data to assess the usability of your device based on your feedback from your users. Link this with your risk assessment and you now have a Usability Engineering File for your device and comply with the standard.
What originally seemed like a mammoth task or a showstopper for some, is not quite so scary.
If you’re looking for support or guidance then why not get in touch. Call us now on 01295 724286 or email us at email@example.com.
IMed MD & Senior QA/RA Consultant