Medical Device Glossary

A natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.

A marking by which a manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

In vitro diagnostic medical devices with low individual and public health risk, including those for self-testing.

In vitro diagnostic medical devices with low individual risk and moderate public health risk.

In vitro diagnostic medical devices with moderate individual risk and high public health risk.

In vitro diagnostic medical devices with high individual and public health risk.

Low risk medical devices that are subject to the least regulatory control. Most Class I devices are exempt from the premarket notification requirements.

Low-medium risk medical devices requiring more stringent regulatory controls than Class I devices.

Medium-high risk medical devices subject to more stringent regulatory controls than Class IIa devices.

High risk medical devices subject to the most stringent regulatory controls including premarket approval.

A systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

A document in which the manufacturer declares that the device meets all applicable requirements of the regulation.

Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market, up until the point of putting into service.

European Database on Medical Devices - the electronic system for registration of economic operators, devices, certificates, clinical investigations, vigilance and market surveillance.

Any natural or legal person established within the Union who places a device from a third country on the Union market.

Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side effect.

The natural or legal person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

A conformity assessment body designated in accordance with this Regulation to carry out third-party conformity assessment activities, including the assessment and verification of quality management systems and technical documentation.

A systematic and planned process to continuously generate, collect, analyse and assess the performance data pertaining to an IVD in order to verify the scientific validity, analytical performance and, where applicable, clinical performance.

Studies conducted to establish or verify the analytical and, where applicable, clinical performance of an IVD.

All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market.

Periodic Safety Update Report - A report providing an evaluation of the benefit-risk balance of a device, submitted by the manufacturer at regular intervals during the post-market phase.

The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

A set of interrelated or interacting elements of an organisation to establish policies and objectives and processes to achieve those objectives in relation to the quality of the devices an organisation designs, manufactures or both.

The systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk.

Testing by lay persons using an IVD specifically designed for testing by lay persons.

Any incident that directly or indirectly led, might have led or might lead to any of the following: death of a patient, user or other person; temporary or permanent serious deterioration of health; serious public health threat.

Documentation that shall contain the information set out in Annexes II and III, as applicable to the device in question, in particular the information required for the conformity assessment of the device.

Unique Device Identification - A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and allows unambiguous identification of specific devices on the market.

A system of reporting, investigation and evaluation of incidents involving medical devices, including the assessment of reported incidents to determine appropriate regulatory actions.