MDR – Article 65 – Clinical investigations on minors

[Ventura]

Article 65 of MDR referes to clinical investigation on minors. What must be the interpretation of the expression "on minors"? Does it include any clinical investigation that may include minors or only those investigations that have minors as the target population?
Lets think about a medical condition like bone grafting, which does not occurs only in minors as required by subparagraph e). For a clinical investigation regarding a medical device for bone grafting one can establish a target population that includes every person in need of a bone substitute. This is not a treatment for a medical condition that ONLY occurs on minors but rather that MAY ALSO occur on minors. Is it possible to include minors in the clinical investigation without making it a clinical investigation on minors?
One logical hypothesis would be to exclude patients younger than 18 years old, but then there will be no clinical data about a population where the medical device can be used...

 

[Junn1992]

As long as you are performing a clinical investigation on a minor, Article 65 applies. Dosen't matter if the minors are a subset of the target population, or whether they are the target population. Why would any competent authority waive this requirement in any scenario?

 

[Ventura]

As long as you are performing a clinical investigation on a minor, Article 65 applies. Dosen't matter if the minors are a subset of the target population, or whether they are the target population. Why would any competent authority waive this requirement in any scenario?

My only question is regarding subparagraph e) that states that "A clinical investigation on minors may be conducted ONLY where (...) the clinical investigation is intended to investigate treatments for a medical condition that ONLY occurs in minors", which is not the case. In accordance to this, can we include minors as a subset of our target population?

 

[Junn1992]

Ah I see what you mean. Good question... I think you need a CA opinion on this. There MIGHT be 2 separate investigations, one with adults, and one with children separately in order to extend the claims to minors.

 

[Raisin picker]

Hi Ventura, my MDR states a different Article 65:

e) the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;

I think that in your case, the second part applies: Your bone graft is tested in adults, but you want to include minors in the patient population, so you need to adhere to article 65 (for the minors).

 

[Ventura]

Hi Ventura, my MDR states a different Article 65:



I think that in your case, the second part applies: Your bone graft is tested in adults, but you want to include minors in the patient population, so you need to adhere to article 65 (for the minors).

Hi. You are correct. The complete subparagraph e) is as you transcribed. But we are also struggling with that second part. We are reading that minors can be used to validate data obtained on adults... Is that it? If this is the case it seems ethically questionable. How do you interpret that second part?

 

[Raisin picker]

My opinion:

1. You have a device that can (in theory) be used for all ages.
2. You successfully perform a trial on adults (omitting all populations that require special attention).
3. You can then claim that your device works for adults.
4. You think that also minors should benefit from the device.
5. You perform a trial on minors, based on 65 (e, second part). You already have a lot of data that can, in part, be applied to minors (good scientific justification!), so your trial on minors could be with lower subject number.

I guess you might be able to combine 2 and 5 to save time.

A lot depends, of course, on the differences you might expect between different patient populations and your device. For a bone graft, there might be significant differences, while for other devices the differences might be almost negligible.