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)?

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Medical Devices Professional
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Hemang Kotecha
Regulatory Affairs Specialist II at Getinge Group
Mike – that would be the business decision, but in my opinion they do not need to be notified.

Karen Boyd
Owner / Operator at QMS Consulting LLC
Mike – I would err on the side of caution and suggest that if there’s a chance that an EU customer could obtain one of these devices, notify them of the EC-REP address change.

Mike Murphy
AVAILABLE NOW: Interim QARA Professional; MDR Readiness
Thanks to all for your input.

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?

Auke Poutsma
Sr.Manager RA/QA & EHS @ Medtronic Trading NL
I know but it would solve the IFU issue immediatly if you could do an update of the IFU on the website. Thanks for your comment.

Michael Malis
Senior Consultant for Regulatory Affairs, Compliance and Quality Assurance
Dear Auke,

E-labeling is not accepted worldwide from Regulatory point of view.

Auke Poutsma
Sr.Manager RA/QA & EHS @ Medtronic Trading NL
Dear Mike, Marcus gave you excellent advise. Foillow the MEDDEV 2.5/10 and indicate to the Authority the transition. Also involve the NOBO as it has labelling impact. I suggest to be transparent to all parties involved. Unfortunately e-labelling is not widely implemented as it would be helpful for the IFU part. The products in the distribution chain will end up in an unavoidable mix-up anyhow as you do not remove product from the market due to the address change. From my experience, this is understood by the CA’s.

Hemang Kotecha
Regulatory Affairs Specialist II at Getinge Group
Mike, to answer your question, there is no set timeframe for updating your labeling. Typically you have around 6 months to update all of your labeling and internal documents for EC REP change. After the update has been made and change implemented, you are also required to notify the NB to update your EC certificates. You may also be required to notify all your customers regarding the change. Check with your respective NB as to what are their expectations.

Michael Malis
Senior Consultant for Regulatory Affairs, Compliance and Quality Assurance
Hi Mike,

There is no exceptions granted.
As Marcus identified correctly above, there are no guidelines or set rules. My recommendation is to put together a project and provide a copy to your notified body ASAP. Plan on updating TF and all labeling and extra time. We were able to plan and save 4 to 6 months of product inventory and it was still not enough time. Part of this because our notified body was very busy and part because all labeling (IFUs, marketing literature, customer letters, etc.) took extra time.

Regards,
Mike

Karen Boyd
Owner / Operator at QMS Consulting LLC
Mike – Apologies for any confusion. I did indicate that wherever possible, updated literature / e-media should be sent to customers who already have product.

Somashekar BV
Sr. Manager at Opto Circuits (I) Ltd
You need to have this well address in your both EC_REP contract agreements. The rest of it can be handled by suitable advisory notices. Rest of the stuff what you do with your printed information is your call. Based on the risk and cost benefit analysis, you can use or scrap the old printed information.

Mike Murphy
AVAILABLE NOW: Interim QARA Professional; MDR Readiness
Thanks again Marcus. I have only now been able to read fully your responses and Joe’s initial posting.. Very comprehensive assessment of project and regulatory requirements.

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?

Marcus Gould
RA/QA Consultant
Hi Mike

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.

Mike Murphy
AVAILABLE NOW: Interim QARA Professional; MDR Readiness
Joe – thank you for posting this question on my behalf. To expand the question a little:

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)?

Karen Boyd
Owner / Operator at QMS Consulting LLC
Excellent advice, Marcus Gould. Very comprehensive!

Marcus Gould
RA/QA Consultant
Apologies, I forgot to mention. The expectations of an EC-REP can be found in MEDDEV 2.5/10 ‘Guidelines for Authorised Representatives’. Even though its not directly related to address changes, it is still relevant to the underlying change of the EC-REP.

Marcus Gould
RA/QA Consultant
Hi Mike

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.

Marcus

Karen Boyd
Owner / Operator at QMS Consulting LLC
Manufacturer must also update regulatory documentation (DoC’s, technical files, etc.) with the EC-REP’s address change.

Karen Boyd
Owner / Operator at QMS Consulting LLC
I believe the labeling change(s) should effect product manufactured as of that change in address date and going forward.
Product already manufactured (and labeled) and in the field prior to the change date would not be affected.
Updates to literature / e-media should be done wherever possible (if in stock with manufacturer and/or updates sent to customers).