IEC 62366-1:2015+A1:2020

agrpyl

Starting to get Involved
For my products I made the usability engineering file in the Year 2017. One of the product is CE certified and the other have FDA. Do I need to update the product's usability engineering file as per IEC 62366-1:2015+A1:2020?
 

AliceQA

Starting to get Involved
I would strongly recommend looking at the changes in A1:2020 version and doing a gap analysis in your UE file, because for CE marking you are required ensure the device is state of the art, and this includes from a safety, performance and compliance perspective.
Your GSPRs will also need to be updated with the A1:2020 version, and you should only claim compliance once you have confirmed your process, UE file and any impact to your risk management file have been assessed.
 

Tidge

Trusted Information Resource
I would only recommend doing a gap analysis under limited circumstances:
  • You are getting complaints that implicate use failures of the system
  • You are considering a design change to mitigate use failures, or are otherwise changing usability features of the device
  • You are considering entry into a new market, and entry into the new market will require external review of the UEF
  • You are considering changing the class of users (i.e. some new consumer group) in an existing market
  • You plan on some formal interaction with a NRTL or regulatory agency specific to the existing devices
It isn't a bad idea to be aware of the differences/updates, but I feel like you would have to have a clear and convincing reason to do a formal gap analysis on existing products. Otherwise this sounds like a get-rich-quick scheme for 3rd party consultants.
 

AliceQA

Starting to get Involved
I've made a very big assumption here that 'One of the product is CE certified' means the device was CE marked under IVDD or MDD, having gone through 4 Class III MDR submissions I can confirm notified bodies are looking for compliance to the most recent version of standards or a good justification as to why it hasn't been done.
I recommend reading MDCG 2021-5 (https://health.ec.europa.eu/system/files/2021-04/md_mdcg_2021_5_en_0.pdf) for CE marking purposes.

If you created your UE file, there's no reason to involve consultants as you know the file better than anyone.
 
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