11. Annex Category Unpacked Base Bulk Remarks UoU Package Package Direct Part Marking Higher package (DPM) configuration Single-use MD IMDRF class A (low-risk) - - DI + PI Flexibility on possible exemption for PI IMDRF class B (medium-r.) - - DI + PI IMDRF classes C+D (high-r.) - DI + PI DI + PI Reusable MD Require reprocessing between uses Not all package levels necessarily exist, e.g.: surgical All risk-classes DI + PI DI + PI DI + PI instruments, intravenous (IV) infusion pumps. Implantable MD PI = Serial number for active implants Sterile - DI + PI DI + PI Usually single packed (1 piece) Often multiple packed ("n" pieces) Must be Non-sterile DI + PI + PI Not necessarily DPM, other technological options allowed to identifiable identify the unpacked MD Others Kits (IVD / non-IVD) - DI + PI DI + PI Concerns the kit package itself SaMD DI + PI DI + PI - Must not necessarily be packed AIDC carrier to be placed on a part‘ ‚main Configurable MD Systems DI + PI - (primary mode of action) DI (linear bar OTC exclusively - - Point-of-Sale scanners can‘t work with PI code) DI + PI PI should be presented in a separate AIDC carrier due to OTC + channels - - scanners
11. Annex Category Unpacked UoU Direct Part Marking (DPM) Base Package Bulk Package Higher package configuration Remarks Single-use MD IMDRF class A (low-risk) - - DI + PI Flexibility on possible exemption for PI IMDRF class B (medium-r.) - - DI + PI IMDRF classes C+D (high-r.) - DI + PI DI + PI Reusable MD Require reprocessing between uses All risk-classes DI + PI DI + PI DI + PI Not all package levels necessarily exist, e.g.: surgical instruments, intravenous (IV) infusion pumps. Implantable MD PI = Serial number for active implants Sterile - DI + PI DI + PI Usually single packed (1 piece) Non-sterile Must be identifiable DI + PI + PI Often multiple packed ("n" pieces) Not necessarily DPM, other technological options allowed to identify the unpacked MD Others Kits (IVD / non-IVD) - DI + PI DI + PI Concerns the kit package itself SaMD DI + PI DI + PI - Must not necessarily be packed Configurable MD Systems DI + PI - AIDC carrier to be placed on a ‚main part‘ (primary mode of action) OTC exclusively - - DI (linear bar code) Point-of-Sale scanners can‘t work with PI OTC + channels - - DI + PI PI should be presented in a separate AIDC carrier due to scanners