Transition calendar: the 2027, 2028 and 2029 milestones and the abolished sell-off period

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the sixteenth instalment; together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are shown in the table below.

1. Key takeaways

Across the four years from 2026 to 2029, three timelines run in parallel in Switzerland: the product registration obligation (mandatory from 1 July 2026, transition expiring 31 December 2026), the legacy device transition (31 December 2027, 31 December 2028, December 2029) and the fee mechanism (first billing on 31 December 2026, regular invoices from 1 January 2027). The three lines are independent of one another, and a delay on any one of them cannot be offset by the grace of another: missing the registration window does not extend the legacy horizon, and an unexpired transition does not excuse a missed billing cut-off.

For planning purposes this means every workstream needs its own owner and its own internal deadlines: the registration obligation is a Swissmedic-facing product task, the legacy transition is a portfolio decision, and the fee mechanism is a finance task — and all three converge on the same small number of calendar dates.

2. Legal basis

3. Expert insights

1. 1 July 2026 is the watershed, and some products have no transition at all. The UDI Devices module was open for voluntary registration from 18 August 2025 to 30 June 2026, becomes mandatory on 1 July 2026, and carries a transition period to 31 December 2026. However, devices subject to serious incident, FSCA or trend reporting requirements have no transition period and must be registered from 1 July 2026 immediately. A company that schedules its work on the assumption of a half-year grace period will step straight over the line on its high-risk product lines.
2. The separation of the billing date from the registration date is the most commonly misread feature of the calendar. The first billing date is 31 December 2026, covering all UDI-DIs with the status On the market on that date; devices marked No longer placed on the market are not charged, and from 1 January 2027 regular invoices are issued for registrations added during the year. This means products registered during the transition are all swept into a single bill on that one 31 December.
3. The three transition milestones correspond to different stock volumes, and resource sequencing should follow them. On the MedDO side, high-risk devices run to 31 December 2027 and medium and low-risk devices to 31 December 2028; under the IvDO, Class D runs to December 2027, Class C to December 2028, and Class B and sterile Class A to December 2029. The IVD long tail (Class B and sterile Class A) has the longest window and is easily deferred to the end — yet it is precisely this segment with the largest SKU count and the densest UDI-DI billing entries.
4. The abolition of the sell-off deadline turns the end of 2029 into a hard wall. Both ordinances have removed the sell-off period, so on expiry of the transition the products on sale and the stock lose their basis simultaneously. Viewed against the annual cap of CHF 10,000 (reached at 491 UDI-DIs, with the 492nd onwards no longer charged), proactively pruning long-tail SKUs reduces both the registration workload and the record-building cost.

4. Practical recommendations

1. Build a four-column calendar (registration obligations, legacy transition, billing milestones, internal milestones) and mark 31 December 2026 as the first company-wide hard node.
2. Maintain a separate list of devices subject to serious incident, FSCA or trend reporting and treat them as having no transition period from 1 July 2026, registering them first.
3. Complete one SKU de-duplication pass before 31 December 2026: mark products confirmed as withdrawn as No longer placed on the market.
4. Launch the legacy device projects in batches against the 2027 / 2028 / 2029 milestones, starting the IVD Class B and sterile Class A long tail early to avoid a resource crunch in the final year.
5. Keep the quality system, with ISO 13485 as one of its baselines, operating effectively, and retain the system audit records from the transition period.

5. Verification checklist

• □ The scope of mandatory registration under Art. 108 has been determined for the position from 1 July 2026.
• □ Devices subject to serious incident/FSCA/trend reporting have been confirmed as having no transition period and are being registered immediately.
• □ The UDI-DI status review for the billing position at 31 December 2026 has been completed.
• □ Legacy devices have been launched in batches against 31 December 2027, 31 December 2028 and December 2029.
• □ The annual cap of CHF 10,000 and the threshold of 491 UDI-DIs are reflected in the budget model.
• □ Quality system (ISO 13485 and similar) certificates and audit records are valid.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway and classification strategy services, including consolidated transition calendars that merge registration obligations, legacy milestones and Swissmedic billing nodes into one plan. For support with your Swiss timeline architecture, contact GRZAN at info@grzanglobal.com.