Medical Devices Regulation (MDR)

The MDR applies to the marketing of medical devices for human use, as well as to the accessories of such devices. It also applies to clinical investigations conducted in the European Union about the medical devices and accessories targeted by the regulation.

With regard to the concept of ‘medical device’, the MDR defines it as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for purposes that include the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. However, to be considered as ‘medical, it is required that the device does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The MDR obliges manufacturers to label their products in an indelible, easily legible and clearly comprehensible way. The label applied to the product must contain a series of information set out in the regulation itself and which include:

• The name or trade name of the medical device.
• The name, registered trade name or registered trade mark of the manufacturer, as well as the address of its registered place of business.
• The lot number or serial number of the medical device.
• Whether there are any special storage or handling conditions that apply to the device.
• Whether the device is intended for single use.

The MDR also obliges medical devices to be marked with a CE marking in order to enter the European market. This CE marking must be affixed visibly, legibly and indelibly to the device or its sterile packaging.

In order to guarantee product traceability and prevent counterfeiting, the MDR obliges manufacturers to include a so-called Unique Device Identifier (UDI) in the product’s label. The UDI is composed of two elements:

• A UDI device identifier (or UDI-DI), which must be specific to the manufacturer and medical device.
• A UDI production identifier (or UDI-PI), which allows the identification of the unit of device production and, if applicable, the packaged devices.