Risk Analysis help for CE Marking Class I Medical Device

T

topher4209

#1
Cove,

As I have posted before, I am trying to get 3 Class I, Rule 1 Technical Files completed so I can obtain an AR for CE Marking. Now I have learned that my Risk Ansylist in my 3 files are not to 14971. They were good enough for the FDA but I don't think for CE. I have read the cove on every thread I can find, found templates but still am not understanding how to complete a Risk analyst for my families.

I know the FDA well but not CE. Any more help I can get would be appreciated. :thanks:

Regards,

Christopher
 
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davishont02

Starting to get Involved
#4
Topher4209, Sarah Stec is absolutely right to direct you to the Harmonized standard EN ISO 14971:2012.

At one point EN ISO 14971 and ISO 14971 was pretty much the same. In 2012, Annex Z of EN ISO 14971 was changed to reflect risk which made my life a brief nightmare. :lmao:

The difference for CE can be boiled down to the following:

  • All identified risks must be reduced as far as possible, regardless of cost.
    • ALARP (AS LOW AS REASONABLY POSSIBLE) to AFAP (AS FAR AS POSSIBLE). Negligible risks cannot be ignored and must be mitigated in some way.
      • Basically no risk is negligible or tolerable and everything must have a risk/benefit analysis done.
      • A lack of budget cannot define "ALARP"
  • Labeling DOES NOT reduce risk.
    • IFU warnings cannot be counted as risk mitigation.
    • IFU cannot affect RPN (risk priority number)
    • Labeling is still required but has nothing to do with your analysis of risk
Hopefully you will find this to be true in your reading of EN ISO 14971. I wish you the best!!
 
C

cadevon

#5
[*]Labeling DOES NOT reduce risk.
  • IFU warnings cannot be counted as risk mitigation.
  • IFU cannot affect RPN (risk priority number)
  • Labeling is still required but has nothing to do with your analysis of risk

    Does "labeling" include notations or directions about product safety in the user manual/technical documents? or does it only mean physical warning labels on a device?
 
T

topher4209

#6
Cove,

My AR is picked, my Technical files are built to the best of my ability, and the information and data I have. Now I assume the next step is to send the AR my files and let them tell me all that is wrong? Also I don't like to assume in the QA/RA industry. :eek:

Warm Regards,

Christopher
 

Sarah Stec

Involved In Discussions
#7
Is your consultant also your AR? Do you know if your AR will review it (as far as I know this isn't a given, but you may have contracted for it)? If not, then you may want to get a consultant to review it to make sure that your tech files meet the regulatory requirements before sending it to your authorized rep.
 
T

topher4209

#8
Yes they will review one of my Technical files. If they fall into the same class product. Which they do. I have 3 total. Per my contract they will review, give feedback (which I'm scared) and proceed from there.

Warm Regards,

Christopher
 

gholland

Involved In Discussions
#9
Cadevon - labeling includes IFUs and user/operator manuals. Anything printed that goes along with the device is included in the 'labeling' category. Hope that helps.

gh
 
#10
i can't understand and agree the following statement:
* Labeling DOES NOT reduce risk.
Sometimes the warning message is the only possible way to reduce the risk in a most cost-efficient way.:notangel:
 
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