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Medical Devices - Topics of Interest

Notified Bodies
A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…
Unique Device Identifier - UDI
The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…
Harmonised standards
Harmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations,
Combined studies
Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
Counterfeiting
Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health.
Custom-made devices
A 'custom-made device’ is made according to a written instruction by any person authorised by national law through their professional qualifications.
Economic operators
The EU medical device regulations, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices, assign specific responsibilities to the economic operators

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