Class IV

Class III

Class II

Class I

UDI Pilot, Rules, UDID Database Tests

Batch 1 Notice timing and list

Batch 1 Delay & 69 (64+5) categories

Batch 1 UDI Data & Label Req’d

Phase 2 Remaining Class III

Class II devices Class I and Remaining devices

Brexit effective, Guidance Released

UK-mfg Class I, Custom, IVD register

III, IIb Imp, Active Imp, IVD A register

IIb other, IIa, IVD B, IVD Self-test reg.

OUK-mfg Class I, Custom, IVD register

CE replaced by UKCA mark; Legislation expected to require UDI

High-risk implantables for coronary stents, orthopedic joint replacement implants & intraocular lenses

Class D (High-risk) for all general medical devices and in-vitro diagnostic (IVD) products

Class C (Medium-risk) for all general medical devices and IVDs

Class B (remaining) for all general medical devices and IVDs

UDI Draft Requirements released

UDI Pilot

UDI Formal Requirements (v3) released

Class B, C and D devices

low-risk Class A devices

ANVISA UDI regulations published

risk class IV medical devices

risk class III medical devices

risk class II medical devices

risk class I medical devices

UDI System Proposal

UDI Consultation Survey

Therapeutic Goods Amendment establish AusUDID

Sandpit (beta) version of the Australian UDI database (for general use and testing)

Third consultation paper

Voluntary compliance (Regulations in effect) for high risk devices (Class II, III, AIMD)

Mandatory compliance for implantable devices. Allocation of UDIs, UDIs on labelling, and provision of data.

MFR voluntarily apply UDI on label of Inclusion List products

National Implant Registry (LIR) started

Healthcare providers must register patient implant data in LIR referencing UDI product data published by MFR in the “GS1 Data Source”

By implication Mfr required to report UDI data to GS1 Data Source and apply UDI on label of Inclusion List products

National Implant Registry live and will remain in place. Netherlands will look to follow the EU/EUDAMED for additional UDI requirements.

Medical Devices Act governing medical devices officially took effect.

Class III Medical Devices – UDI database registration & label required.

Class II Medical Devices – UDI database registration & label required.

Class I Medical Devices

Implementation of the “Swiss Database on Medical Devices” aka “SwissDAMED” started by Swissmedic.

Actor registration possible.

Product registration possible (on a voluntary basis).

“Actor Module” in development.