Hello Shikha,
As you can see there is some work which has to be performed as not a simple yes/no answer to the question whether it is a significant change. It also depends on what your current labelling and claims are saying concerning a paediatric population. If indeed the paediatric population is to be contra-indicated then potentially a significant change. If a paediatric population was never really intended, and just used to clarify in the labelling, then might not be a significant change. It depends on the device, how the device is used, the labelling, and intended purpose of device. For the US FDA, this usually would not require a new 510(k) as limitations to the population can be done as part of documented change control. However, again if the removal of the paediatric population is for a safety concern or contra-indication purpose, then potentially a market correction or new 510(k) submission may be needed. The FDA is fairly consistent now with labelling indicating the population for the intended use of the device, so if you already have a 510(k) cleared, this should be reviewed in detail to understand any impact.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 11-Dec-2023 06:06
From: Carole Robin
Subject: EU MDR Pediatric Usage Question
Dear Shikha,
When there is a change in the target population, such as removing the pediatric population, this population may become a contra-indication population so you are right this is a significant change .
Stopping selling the device in the EU is linked with the change you will submit to the NB or up to the end of the certificate of CE marking if there is no risk for this specific population. The removal from the market will have to be declared to the local competent authorities where the device is sold when this is required.
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Carole Robin
Regulatory & Clinical Affairs Advisor
CR MED Consulting
Lyon
France
Original Message:
Sent: 10-Dec-2023 03:54
From: Ronald Boumans
Subject: EU MDR Pediatric Usage Question
Dear Shikha,
I agree with Erik that restriction of the target population would not be considered a significant change because there is no need for additional clinical evidence for the remaining population. This may result in an interesting situation. Previously the device was certified for pediatric patients and then the risks were acceptable when weight against the clinical benefits. If this is no longer the case, how will physicians know that they can no longer use the device as they used to? You are now opening the door to off label use that may turn into misuse and cause injuries to patients. You may want to carefully think about how to communicate this, or at least add a special paragraph to your PMS plan about this change.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 08-Dec-2023 14:17
From: Shikha Malik
Subject: EU MDR Pediatric Usage Question
Hello all,
I was hoping to get some insight on a prospective change to the target population of a class III product in the EU. We are planning to remove the pediatric population from the product intended purpose. Therefore, I assume this could be considered as a significant change per MDCG 2020-3 and we will no longer be able to sell the EU MDD version of the product. Any thoughts on this?
Also, if you concur with my initial assessment. What should be the planned date for stopping selling in the EU?
Is this change require a US 510(k) submission?
Thanks!
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Shikha Malik
Sr. Regulatory Affairs Specialist
Medtronic, Inc. - ENTERPRISE
Frisco TX
United States
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