Permanent wrinkle filler that remains in the body throughout the patient’s life, for non-reconstructive purposes
Decree on medical devices
Medical devices and in-vitro diagnostic medical devices make a key contribution to patient quality of life and health. This encompasses a highly diverse group of products: from plasters, artificial hips and pacemakers to laboratory tests and self-tests.
Regulation (EU) 2017/745 and Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices and in vitro diagnostic medical devices (hereinafter the ‘Regulations’) were published on 26 May 2017.
After entry into force of the Regulations, which provide for the repeal of several formerly applicable directives, they came into immediate force in the national law of the Member States. Proper implementation of the Regulations, however, requires additional national laws and regulations in several areas. The main subject matter of the Regulation is implemented in the Medical Devices Act [Wet medische hulpmiddelen]. This Act also contains some principles for establishing rules in general administrative regulations. The Decree provides for the establishment of these rules.
The Decree also sets out, among other things, additional rules on the provision of implant cards to patients, a ban on permanent wrinkle fillers, and the reprocessing of medical devices.