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A question from group member Mike Murphy QA Consultant, Combination Product Launch at The Medicines Company:
Can anyone share experience of change EC-REP address (within the same country or otherwise)?
How much time do NCA’s allow to remediate IFU’s and related literature for a serialised device installed base?
Are any exceptions allowed or is the expectation set at 100% adjustment of all existing EC-REP references in distributed literature and e-media in the marketplace?
What about CE-marked labeling outside of Europe (e.g. US)?
Back to the last point of the original posting. What about installed base in e.g. U.S. Market where 110V devices are extremely unlikely to find usage in Europe – must these customers also get notification?
E-labeling is not accepted worldwide from Regulatory point of view.
There is no exceptions granted.
Karen – I am a little surprised by your suggestion that there is no need to address the labelling change in the market, especially for serialised devices. Seeing as these devices can exist indefinitely in the field, some notification to holders of installed vase devices is expected? This approach may be more suited to consumables?
Based on past experience there are no guidelines or set rules on how much time competent authorities will allow, or if they will grant exemptions. I can suggest going through the steps I highlighted in my previous post to put together a project plan and submit to your notified body and lead competent authority. Use this project plan to start discussions with your notified body and lead competent authority and get their thoughts and direction. All the above steps need to be completed before labels with the new EC-REP address can placed on the market. Some competent authorities may allow you to draw down your inventory of ‘old’ labels after you formally change to the new EC-REP before requiring you to put the ‘new, labels on the market, however some competent authorities will demand you have only the new labels being placed on the market. These options need to be discussed with, and determined by, your lead competent authority and your other competent authorities. Of course your notified body may have conflicting demands and these have to be factored in if required. Only your notified body and lead competent authority can give you the definite answers and direction.
How much time do NCA’s allow to remediate IFU’s and related literature for a serialised device installed base? Are any exceptions allowed or is the expectation set at 100% adjustment of all existing EC-REP references in distributed literature and e-media in the marketplace? What about CE-marked labeling outside of Europe (e.g. US)?
In addition to Karen’s comments there are a number of other steps which need to be undertaken when changing the EC-REP:
* Inform (where required) all relevant competent authorities that the EC-REP has been changed
* Inform the respective notified body(ies) of the change of EC-REP
* Update the agreement between the legal manufacturer and the EC-REP. This is one thing the notified bodies will definitely want to see.
* Ensure the EC-REP address meets the address requirements stipulated in EN 1041:2008
* It may be possible, depending on the class of the device, that the labelling change would be a ‘substantial change’ to the respective notified body. Determine if it is and draw up the documentation and submit to the notified body for review and approval.
* Identify all products and labelling that is affected, and determine the amount of labelling that has already been placed on the market, that is held in the company’s warehouses ready for shipment, how much is currently being manufactured, and how much labels are within inventory. In addition determine the turnover rate of each device, and from this determine the estimated date the labels with the ‘old’ EC-REP address shall be used. Present these findings to the relevant competent authorities and seek their opinion. Some may ask that all labelling is immediately change, however some may give a grace period. This may lead to a situation where you have labels with both ‘old’ and ‘new’ EC-REP addresses on the market – ensure the ‘old’ address will still allow the forwarding of any CA and/or vigilance/customer complaint to the ‘new’ EC-REP address for auctioning.
* Determine the cost of printing new labels and disposing of old labels. Depending on numbers it may be more economically viable to stay with your current EC-REP!
* Because all CE marked labels will be touched with the new EC-REP address it is now a good time to review the other symbols, content, UDI requirements etc. of the labels to ensure they are fully compliant with current and future requirements. It will save time and expense having to touch the labels again at a later date.
* Likewise, if you are changing the EC-REP address on e-media, make sure the e-media fully complies with the e-labelling regulation
* Validate the printing process of the labels as new plates will need to be used.
* It is also possible that some markets which accept the CE mark, such as ANZ and Latin American countries will view the labelling change as a substantial change, and so therefore their regulatory bodies will need to be informed and the labelling strategy discussed with. Identify all countries to which CE marked labels are going to and obtain intelligence from the subsidiaries (if applicable) or direct with the regulatory bodies.
* Of course this should all go through your company’s change control procedure for a full regulatory and quality assessment.
It is hard to give actual answers to your questions because it will of course depend on your company’s products, class, actual and future installed base and marketing requirement, but I would definitely recommend talking to your competent authority and notified body for their thoughts early in the process.
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