Essentials of European Medical Device Regulatory Affairs - October 2019

Classification – Key Concepts

Rules apply according to intended purpose - :

Duration:

transient (<60 mins) short term (<30 days) long term (>30 days)

Invasiveness:

Non-invasive invasive in a body orifice (eyes/stoma) surgically invasive implantable (hip replacement)

Non-Active/Active:

63

Concept of Time • Application quick, but in situ for longer e.g. cream • Continuous use: uninterrupted actual use of the device for the intended purpose. • However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device

Ref: Directive 93/42/EEC Annex IX Sect 2.6 Chapter II

64