Four keys in sequence: CE marking, CH-REP, CHRN and swissdamed registration

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the eleventh 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

The four keys follow a legally prescribed order and cannot be run in parallel or reversed: first complete conformity assessment and affix the conformity mark, then appoint the Swiss authorised representative (CH-REP), after which the manufacturer or the CH-REP completes the economic operator registration and obtains the Swiss single registration number (CHRN), and finally the device-level UDI-DI registration is completed in swissdamed. Where a manufacturer located outside Switzerland has not appointed a CH-REP in writing in accordance with Art. 51(1), its devices may not be placed on the Swiss market; skipping an earlier step and moving directly to a later one will lead to the shipment being blocked at the importer verification stage (Art. 53(1)) or the distributor verification stage (Art. 54(1)). The practical estimate for planning purposes is that each key gates the next one, so the sequence itself is the compliance strategy: budgets, documentation work and appointments should be scheduled against the four gates in this fixed order rather than treated as independent workstreams that can be compressed or reordered at will.

2. Legal basis

3. Expert insights

1. The first key is conformity assessment, not registration. Art. 6(1)–(2) expresses the conditions for placing a device on the market as two parallel requirements: conformity with the MedDO itself, and satisfaction of the general safety and performance requirements (GSPR) set out in Annex I of the EU MDR. Under Art. 13(1) the conformity mark may be the Swiss Annex 5 mark or the CE mark under Annex V of the EU MDR. This means Switzerland does not issue a separate Swiss certificate: what a company actually holds is the combination of a European conformity assessment outcome and a Swiss local entity arrangement. Budgeting for a so-called Swiss registration certificate is a directional mistake, because no such standalone document exists in the system.
2. The second and third keys concern the entity, and only the fourth key concerns the product. The appointment of the CH-REP takes place at the entity level, the CHRN is allocated by Swissmedic after verifying the economic operator information (Art. 55(4)), and the UDI Devices module registration in swissdamed sits at the product level. The regulatory logic is therefore entity first, product afterwards: without a CHRN there is no responsible entity to which a UDI-DI can be attached. The economic operator registration channel has been open since 26 November 2021, and the Actors module went live in August 2024. The two timelines show that Switzerland deliberately built the entity database before opening the product database.
3. The time obligations are scattered across three provisions, and the shortest one is the easiest to miss. Art. 55(1) allows 3 months from first placing on the market to register; Art. 55(2) requires changes to be reported within 1 week; and Art. 108, together with the amendment of the IvDO of 20 November 2024 (AS 2024 742), makes registration in the UDI Devices module mandatory from 1 July 2026, with a transition period ending 31 December 2026. When these three deadlines run in parallel, the shortest one — the 1-week change reporting duty — is usually breached first, precisely because it is the least conspicuous obligation on paper.
4. Costs arise at the product level and roll annually. The fee structure in Annex 2 charges CHF 200 for the first UDI-DI, CHF 20 for each additional UDI-DI within the same year, and a cap of CHF 10,000 per manufacturer or SPPP per year (reached at 491 UDI-DIs, with the 492nd onwards no longer charged). The first billing date is 31 December 2026, covering all UDI-DIs with the status On the market on that date. Managing device status updates (No longer placed on the market) in coordination with the billing cut-off is the only legitimate way to reduce the invoice.

4. Practical recommendations

1. Build the project plan as conformity assessment of the product, then entity registration, then product registration, and treat any attempt to bring a step forward past its predecessor as a hard gate that cannot be skipped.
2. Set the date of first placing on the market as the global baseline date: run the 3-month registration deadline and the 1-week change deadline from that date, and maintain two separate ledgers for the two clocks.
3. Use 31 December 2026 as the trigger for a full UDI-DI status review, marking products that have been withdrawn from sale as No longer placed on the market before the billing cut-off applies.
4. Consolidate fee exposure at the manufacturer or SPPP level rather than the CH-REP level; for entities outside Switzerland the invoice is sent to the CH-REP, so the mandate letter must specify who receives and repays the invoice.
5. Establish the quality system on the basis of ISO 13485 and retain certification evidence to support the system requirements of Art. 50 and Article 10 of the EU MDR.

5. Verification checklist

• □ Conformity assessment has been completed and the conformity mark affixed to the device itself or its packaging in accordance with Art. 13(1) and Art. 14 (Swiss Annex 5 mark or CE mark).
• □ The manufacturer located outside Switzerland has appointed a CH-REP established in Switzerland in writing in accordance with Art. 51(1), with a mandate covering the formal and safety matters of Art. 51(2).
• □ Within 3 months of first placing on the market, the information in Section 1 of Part A of Annex VI of the EU MDR has been submitted and a CHRN obtained (fixed fee CHF 200, Swissmedic processing up to 30 days).
• □ Changes to the registered information have been reported within 1 week in accordance with Art. 55(2).
• □ The registration status in the swissdamed UDI Devices module is consistent with the billing position as at 31 December 2026.
• □ Quality system documentation (including the ISO 13485 certificate) and the device technical documentation are archived and retrievable on demand.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with end-to-end registration pathway planning and classification strategy: sequencing conformity assessment, CH-REP appointment, CHRN registration and swissdamed UDI-DI filings into one gated timeline, maintaining the 3-month and 1-week ledgers, and aligning device status with the annual fee cap. For tailored advice on your Swiss market entry sequence, contact GRZAN at info@grzanglobal.com.