Products without an intended medical purpose
Going forward, requirements will be imposed on manufacturers of certain products not previously comprised by the rules on medical devices. The medical devices regulation contains a list of some groups of products that will be regulated as medical devices. These are products falling outside the definition of a medical device because the products do not have an intended medical purpose. The products are listed in Annex XVI of the regulation and covers the following product groups:
- Contact lenses without prescription, e.g. coloured contact lenses
- Products for the purpose of modifying the anatomy, e.g. implants with a cosmetic purpose (horn implants or breast implants if the purpose is exclusively cosmetic)
- Products for facial injection or other injections (fillers)
- Products to remove adipose tissue such as equipment for liposuction
- Products for electromagnetic radiation such as laser for tattoo or hair removal
- Products intended for brain stimulation applying electrical currents or magnetic or electromagnetic fields, e.g. to stimulate memory or concentration
Manufacturers of products without an intended medical purpose must comply with the rules of the medical devices regulation and must moreover comply with a number of detailed rules (common specifications) that apply specifically to products without an intended medical purpose. Manufacturers of products without an intended medical purpose will, like medical device manufacturers, need to register with and pay a fee to the Danish Medicines Agency (in Danish).
Companies manufacturing, importing or distributing products without an intended medical purpose will also be required to notify the Danish Medicines Agency of any relationships they have with healthcare professionals or economic support offered to a healthcare or other professional, cf. section 5B(5) of the Danish Act on Medical Devices.
The rules of the regulation will apply from 22 June 2023.
Not before this date will manufacturers of products without an intended medical purpose be required to register with or pay a fee to the Danish Medicines Agency. Companies manufacturing, importing or distributing products without an intended medical purpose will also not be required to notify their relationships with healthcare professionals or economic support offered to healthcare and other professionals before this date.