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:
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!
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!