AIMDD — Active Implantable Medical Devices Directive 90/385/EEC

The directive that governed active implantable devices such as pacemakers and implantable defibrillators before the MDR, repealed by the MDR subject to transitional provisions.

Reference: MDR Article 122

Gap assessment

A structured comparison of existing technical documentation and processes against the requirements that now apply, producing a list of what must change. An industry practice rather than a regulatory requirement, most often run when moving a device from the directives to the regulations.

Grandfathering

Carrying a device’s existing approval forward into a new regulatory framework without reassessment. The MDR contains no such mechanism: devices certified under the directives must be assessed against the regulation, with the transitional provisions governing only how long the old certificates remain valid.

Legacy device

A device CE marked under the Medical Device Directive 93/42/EEC or the Active Implantable Medical Devices Directive 90/385/EEC and placed on the market under the MDR transitional arrangements. Not an MDR term: it comes from guidance, and it governs what level of clinical evidence is expected during transition.

Reference: MDCG 2020-6

MDD — Medical Devices Directive 93/42/EEC

The directive that governed most medical devices in the EU before the MDR, repealed by the MDR subject to transitional provisions. Devices certified under it are referred to in guidance as legacy devices.

Reference: MDR Article 122