On April 5th, 2017, two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety has been published.
Some key points:
- Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
- Unique Device Identification system (‘UDI system’) is introduced, and it is established an European electronic system for Unique Device Identification (‘UDI database’)
- Many aesthetic products are regulated as medical devices and subject to stricter controls.
- New rules and procedures for clinical trials.
MediCon Ingegneria has the knowledge and the resources to develop and produce Medical Devices in accordance to the New Regulations.