IFUs (Instructions For Use) - EU e-Labeling 207/2012

Java23

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#1
:confused: Sorry for the length of this but, I am trying to paint a clear picture... :)
I am working on creating a risk assessment for e-labeling of Class IIa and IIb medical devices which I need to submit to our notified body. I am following the guidance from the EU whereby there are 10 elements (a thru j) we need to assess along with the 11 items listed (a thru k) for the requirements to provide electronic labeling.

I have performed a gap analysis and have found some gaps and am creating work instructions to fill some of those gaps.

We provide our IFUs on Website and also send 1 CD per bulk shipment (product is prescription devices sold to hospitals/health care facilities). Additionally, we supply a pamphlet with instructions for using the CD and and website to access the IFUs. One pamphlet is shipped with each device. Additonally, we "strongly recommend that the customer print a paper copy of the IFU which can be used if access to the electronic version is interrupted. The pamphlet also gives the phone number (toll-free) for customers to contact in the event they would like a paper copy sent to them.

Article 5 of the regulation states:
 ​
 (3) they shall have a system in place to provide the instructions for use in printed paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;

My interpretation of this is that the customer should receive the printed paper copy no later than 7 days of receiving the request and someone else interprets this as the paper copy should be shipped within 7 days of receiving the requests.

My thought is that since the entire assessment should be based on risk / safety, the sooner the customer receives the IFU, the better.

Hoping that some of you can chime in and help me in the interpretation of the requirement. I am baffled and confused and stuck on this issue. This is one of the gaps I identified wherby we do not have a "document" work instruction in place. Thank you for any thoughts and advice you can give me! :thanks:
 
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Java23

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#3
Maybe a better question is: Has anyone done the documented risk assessment and if so, any suggestions for the way (format) it was presented to your Notified Body?

Thank you :)
 

Java23

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#5
:thanx: Thanks Sam - I have communicated with you here before and very much appreciate your comments and the sharing of your knowledge.

It amazes me that I have been unable to find much on how industry is performing the risk assessment. I need to wrap the assessment up and send it next week and am struggling with how to present it.

My boss told me to use a FMEA spreadsheet and tweak it to make it work but, I am not grasping how a FMEA fits with e-labeling. Just does not make sense to me! Would that work? I have zero experience with FMEA work sheets.

I am thinking of adding a column to the gap analysis and adding a risk association along with an executive summary statement.

Thank you again - much appreciated - wish me luck :cfingers:
 
#6
MF 3009,

May I ask you which guidance are you following to asses risk related to e-labelling?

I couldn't find any EU guidance on that, apart from MEDDEV guidance to IVDs...

Thanks in advance,

Noemi
 

Java23

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#7
Noemi -

I have not found a guidance however, there are multiple risks listed in the regulation in Article 4. Other than that, I have been searching the web and finding some articles that mention the risks which must be evaluated. I feel that performing the risk requires input from IT, Marketing, Customer Service etc. so, at least for me, it has not been easy to respond to the risks without the help of others.
 

Marcelo

Inactive Registered Visitor
#8
My boss told me to use a FMEA spreadsheet and tweak it to make it work but, I am not grasping how a FMEA fits with e-labeling. Just does not make sense to me! Would that work? I have zero experience with FMEA work sheets.

I am thinking of adding a column to the gap analysis and adding a risk association along with an executive summary statement.
You should be using ISO 14971.
 

Java23

Involved In Discussions
#9
Thank you Marcelo - I didn't even think of going to ISO 14971. Makes sense though. Well, guess my day is planned - lots of reading - thank you for your advice. Much appreciated :):thanx:
 
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