UDI implementation timelines

A compact overview of planning defaults and operational constraints used in our Swissdamed/EUDAMED cockpit templates.

General information only. Not legal advice. Private detail sharing available (private agreement / limited scope / selective sharing).

Snapshot Constraints Fit References Verify integrity

Timeline snapshot (planning defaults)

Use these dates for portfolio triage and roadmap defaults. Always confirm against official sources.

Switzerland (Swissdamed) — planning defaults

Post-incident planning deadline: 2026-07-01
Legacy planning deadline: 2026-12-31
New (CH placed-on-market): from 2026-07-01 onward

These dates are used as portfolio defaults in our roadmap templates (not a legal guarantee).

EU (EUDAMED) — planning defaults

Legacy EU planning deadline: 2026-11-28
New MDR/IVDR: class/module dependent (not pinned here)

For official obligations and dates, see References.

How to use these defaults

These dates are planning defaults used in our internal roadmaps. They are not legal obligations and may change.

Use for triage: prioritize legacy vs new portfolios
Lock scope first, then validate data completeness
Confirm deadlines against official sources before committing
Attach evidence (checksums, manifests) to make handovers audit-ready

UDI Ops References Verify integrity

Operational constraints

Data hygiene

ISO dates: YYYY-MM-DD
URLs: http/https only
Floats: dot decimal (.)

These constraints reduce silent failures and improve reproducibility.

Evidence & integrity

Environment capture (what was validated against)
Checksums/manifests to detect drift
Release verification via integrity manifests

Designed for audit narratives and handover-ready operation.

Readiness statuses

PASS: validation executed and no blocking errors
CONDITIONAL: output built but validation pin is missing/unknown
FAIL: validation errors or schema failures

Simple triage semantics that scale across portfolios.

Where this fits

These timelines and constraints support execution planning, portfolio triage, and audit-ready submissions for Swissdamed/EUDAMED. For official regulations and standards, use References.

UDI Ops Resources Contact options

Last updated: 2025-12-20