Risk Analysis help for CE Marking Class I Medical Device

T

topher4209

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
 
S

Sarah Stec

Have you already tried using the tools in the informative/normative annexes in EN ISO 14971 to build your risk analysis?
 

davishont02

Starting to get Involved
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

[*]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

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
 
S

Sarah Stec

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

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
 
G

gholland

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
 
O

Oscar Wang

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:
 
Top Bottom