MDD for Drug Product for CE Marking

[BOOKS]

Would anyone know if there is MDD for combination device with a drug product?

I'm completing the Technical file for the device but still debating if I should include information on the drug. I need some guidence.

I appreciate your input.

[Gert Sorensen]

Originally Posted by BOOKS

Would anyone know if there is MDD for combination device with a drug product?

I'm completing the Technical file for the device but still debating if I should include information on the drug. I need some guidence.

I appreciate your input.

I split this one of to keep the threads clear of clutter

There is - as far as I know - no MDD for combination drug/devices. So if you are into combination products (drug/device) then you will need to consult your notifying body. The documentation should include everything that you would have to generate for a device, however you need to be absolutely clear whether the product will be/is classified as a drug or a device (what is the dominant feature? This is where you need you NB).
As far as I know a device may actually be classified as a drug if the dominant feature of the device is the effect of the drug. Documenting drugs is a whole new ballgame that is hitting medical device companies these years, and not a lot of people seems to know how to deal with this, and those who do "seem to know" generally haven't tried to document anything in their life

[bio_subbu]

According to the Indian Central Drugs Standard Control Organization declared that some of the medical devices also considered as drugs. I don’t know about your product and how your devices classified in MDD directive. If you think your products combination of drug and medical devices, you must consult your notified body.

For your information, please check the CDSCO URL

http://www.cdsco.nic.in/medical%20device%20A42.html you can find out list of medical devices which considered as drugs.

Regards,
Subbu