Hi Christina and Dolores, sorry for the late reply, but I’m really not sure that Rule 21 is applicable for transdermal patches - as I understand it, it was meant to be for self-care substance based devices like cough syrups, lubricating or protective nasal or throat sprays etc - and to address the issue of claims being made for things like cranberry juice being a medical device after absorption. I can definitely see why you read that it could apply though, without knowing the background.
Some examples given by AESGP at the TOPRA Symposium 2018 were:
- Nasal sprays
- Eye drops
- Anti flatulence products
- Laxative capsules
- Moisturizing cream
- Ultrasound gel
- Intimate lubricants
- Nail treatments
- Throat pastilles
It would be great to have clarification somewhere - maybe in the borderline document under development by the MDCG? In the meantime, @theresa.jeary maybe you could comment for us? Or if anyone else has experience of Rule 21 being applicable, that would be helpful.
From the EMA website, they may be asked to review if a substance based medical device is systemically absorbed:
Medical devices made of substances that are systemically absorbed
Some medical devices are made of substances that are absorbed by the human body to achieve their intended purpose.
These devices are normally introduced into the human body via an orifice or applied to the skin.
Role of EMA
Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA or a national competent authority on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC.
EMA will provide further information on the consultation procedure between the notified body and a competent authority or EMA.
See the EMA medical devices page: Medical devices | European Medicines Agency
Hope this is helpful!