From 22 June 2023, the Medical Device Regulation (MDR) will also apply to certain types of devices without a medical purpose
The rules of MDR will from 22 June 2023 apply to more types of products. The changes are implemented on the background of the EU Commission's Implementing Regulation of 2 December 2022 laying down common specifications for devices without a declared medical purpose which are covered by Annex XVI of the MDR.
This means, among other things, that manufacturers, importers, distributors, authorised representatives and specialised dealers of these devices are obliged to register with the Danish Medicines Agency from this date.
The covered non-medical devices listed in Annex XVI of the MDR currently include the following products:
- Non-powered contact lenses, such as colored contact lenses
- Devices to modify the anatomy, such as implants with a cosmetic purpose (breast implants if they have only a cosmetic purpose)
- Products for injection, for example in the face (so-called 'fillers')
- Products to remove fatty tissue, for example liposuction equipment
- Products with electromagnetic radiation, such as lasers for removing tattoos or hair
- Devices for brain stimulation with current or electromagnetic fields, for example to stimulate memory or concentration
From 22 June 2023, the above-mentioned operators are obliged to register with the Danish Medicines Agency. Registration must be done via the Danish Medicines Agency's website and can only be done from 22 June 2023. The fee rates are in line with those that apply to the actors previously subject to registration. An overview can be found on the Agency's website (Danish).
Manufacturers who manufacture such products without a medical purpose in risk classes IIa, IIb and III, as well as importers and distributors of this type of products established in Denmark, should also be aware that from 22 June 2023, they will also be subject to the rules on affiliation and must therefore report annually to the Danish Medicines Agency information on the healthcare professionals that the company has had affiliated with the company.
Want to know more?
If you want to know more about the rules for devices without a medical purpose but covered by the MDR, please contact Plesner's Life Science team.Read the Danish Medicines Agency's newsletter about Medical Devices (in Danish).
Read more about products without a medical purpose.
Read the Medical Devices regulation.
Read Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022.
Read more about the affiliation rules.