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.
Contact us for further information !
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