Are dermal fillers & PDO sutures for aesthetic purpose under CE MDD?

[jooyell]

Are dermal fillers & PDO sutures for aesthetic purpose under CE Medical Deviced Directive?

Filler is in general mainly for aesthetic use and 98% of all end users will use it for this purpose, however current Europe legislation set criteria for the device to be classified as medical device, which are described in the directive. However, there must be some disease for which treatment the device is intended to be used according to the definition of MD in the directive.
How can these products be under CE MDD?

 

[Ronen E]

Are dermal fillers & PDO sutures for aesthetic purpose under CE Medical Deviced Directive?

Filler is in general mainly for aesthetic use and 98% of all end users will use it for this purpose, however current Europe legislation set criteria for the device to be classified as medical device, which are described in the directive. However, there must be some disease for which treatment the device is intended to be used according to the definition of MD in the directive.
How can these products be under CE MDD?

Hi,

PDO sutures are sometimes indicated for medical purposes (see (broken link removed) for example), so can be easily classified under the MDD (depending on the indications for use).

This paper, issued by the UK government in February 2014, is eye-opening WRT the regulatory status of dermal fillers in the EC. I'm not sure what has changed since; I suspect that not much at the EC regulation level. Perhaps the UK already moved forward, and maybe other EC countries too.

 

[Pads38]

It is recognised that dermal fillers should be properly regulated, as at present, there is no control either to what they are or who uses them. They will be included in the forthcoming EU Medical Device Regulations (the replacement to the Device Directive).

 

[Julie O]

If you can show that they are used for a "medical purpose," then you can CE Mark them under the MDD, even if this is not their primary use. In the US, the best indicator of aesthetic vs. medical purpose is who is paying for it. Third-party payors don't pay for purely aesthetic procedures. Some devices developed with aesthetic uses in mind are also used in reconstructive procedures to repair damage due to stroke or trauma.

The catch is that any clinical data you have that reflects use of the device for an aesthetic purpose may not be accepted to support its use for a medical purpose. At least not for now. As Pads notes, it is anticipated that some aesthetic devices will be more directly addressed in the new MDD. However, there is currently no new MDD and, to my way of thinking, what will be addressed in a new MDD remains TBD until a new MDD is actually adopted.

I will add that it isn't inherently necessary for a medical device to be CE Marked/conform to the MDD to be properly regulated. CE Marking was developed to facilitate trade between and within the EU, by alleviating the need to comply with the myriad of different regulations of each of the individual Member States, not to assure that products are properly regulated. I can't speak to either of these two products specifically, but the Member States have always had their own regulations to assure that products sold in their countries are properly regulated. Whether these regulations will ever be fully replaced by the MDD, only time (and politics) will tell.

 

[Ronen E]

it isn't inherently necessary for a medical device to be CE Marked/conform to the MDD to be properly regulated.

IMO, this is a misleading / self contradicting statement, or at least a poorly put one. If a product that is placed on the EC market is deemed a Medical Device (by the EC definition, as given in the MDD) it has to conform to the MDD and be CE marked as applicable. This is a minimal condition of it being properly regulated (and legally marketed) in the EC.

 

[Julie O]

I actually did not realize this. Thanks, Ronen, for this one last good bit of information.

 

[Marc]

Thanks for the help, Ronen. As always, we appreciate your helping people here.