Up-classification

A device moving to a higher risk class under the regulation than it held under the directives, usually because of a changed or newly added classification rule. The consequence is a different conformity assessment route and, often, notified body involvement where there was none before.

Reference: MDR Annex VIII

User

Any healthcare professional or lay person who uses a device.

Reference: MDR Article 2(37); IVDR Article 2(30)

Vigilance — Vigilance reporting

The reporting of serious incidents and field safety corrective actions to competent authorities within prescribed deadlines, followed by investigation and, where needed, corrective action. Distinct from post-market surveillance, which is the wider ongoing data-gathering activity.

Reference: MDR Article 87; IVDR Article 82

WET — Well-established technology

A mature technology for which extensive, long-standing experience exists. The MDR does not define the term, but uses the concept in two places: exempting certain class IIb implantable devices from device-by-device technical documentation assessment, and exempting certain implantable and class III devices from the requirement to conduct clinical investigations.

Reference: MDR Article 52(4) and Article 61(6)(b)

Withdrawal

Any measure aimed at preventing a device in the supply chain from being further made available on the market.

Reference: MDR Article 2(63); IVDR Article 2(66)