Change Management and Version Control: The One-Week CHRN Reporting Boundary

This article is issue 30 of Volume 3, Registration Dossiers and Technical Requirements, of the 50-article series on medical device registration in Switzerland. Together with the other nine issues in this volume it forms a complete deliverable on this topic; the publication timestamp, issue number, title and unique URL are shown in the table below.

1. Key takeaways

Swiss change reporting has one hard boundary: when economic operator data change, the change must be reported to Swissmedic within 1 week. MedDO Art. 55(1) requires the manufacturer or its authorised representative, together with importers, to register the information in Section 1 of Part A of Annex VI of the EU MDR with Swissmedic within 3 months of first placing on the market; Art. 55(2) requires changes to be reported within 1 week; and under Art. 55(4) Swissmedic verifies the data and assigns the Swiss single registration number (CHRN). The 1-week deadline targets economic operator registration data, not product changes — mixing the two categories is the deadline mistake companies most often make in Switzerland.

2. Legal basis

3. Expert insights

1. The test for the one-week boundary is one question only: does registered data change? Art. 55(2) applies to the information registered under Art. 55(1), that is, identity and contact data of the economic operator. Company name, registered place of business, contact address, a change of CH-REP and changes of PRRC personnel therefore fall into the 1-week window. Product-side design changes, material changes and revisions of the instructions for use do not fall under this provision; they follow the technical documentation update route and, where applicable, the notified body change assessment route. The test is simple: open the swissdamed Actors module and ask whether the change would modify a submitted field — if yes, it enters the one-week process; if no, it follows the product change process. Confusing the two is costly in both directions: reporting product changes as registration changes produces a flood of ineffective filings, while handling registration changes as product changes directly violates the statutory deadline of Art. 55(2).

2. The three-month first registration deadline and the one-week change deadline must be read together. The 3 months of Art. 55(1) run from first placing on the market, and Art. 55(5) additionally requires assemblers of systems and procedure packs to register their name and contact address within 3 months of first placing on the market, with representative information included where a representative is required under Art. 51(5). The practical risk window: a company starts the CHRN application only after first placing on the market, yet Swissmedic takes up to 30 days to process an application; if an objection requires corrections, they must be submitted within 30 days or the application is rejected. In other words, at least 30 days of the 3-month window are external processing time, and the time actually left for internal preparation is shorter than it looks. Completing the CHRN application before first placing on the market is the only sequence with no deadline risk.

3. The cost logic decides whether frequent registration changes are worth it. Data updates in swissdamed are themselves free, but two rules on device registration fees are relevant here: the first UDI-DI costs CHF 200, each additional UDI-DI in the same calendar year costs CHF 20, and the annual cap per manufacturer/SPPP is CHF 10,000; re-registration after invalidation requires a new fee. This creates a paired strategy: on one side, updating registration data promptly carries almost no direct cost, and delay carries compliance risk; on the other, invalidating a device in swissdamed and registering it again generates fresh fees. The sensible rule is therefore to update registration data frequently and invalidate device entries with care — the former is free, the latter re-opens the fee meter every time.

4. Practical recommendations

1. Build a change classification table: tier one covers registration data changes under Art. 55(1) (reported within 1 week); tier two covers product technical changes (technical documentation and notified body route); tier three covers internal document revisions (archived only).
2. Fix the field list in the swissdamed Actors module; any change to a listed field triggers the tier-one process, with filing acknowledgements retained.
3. Move the CHRN application forward to before first placing on the market, reserving Swissmedic’s up to 30 days of processing time and the 30 days needed for corrections.
4. Assemblers of systems and procedure packs register their name and contact address within 3 months of first placing on the market under Art. 55(5), including representative information where required.
5. Do not invalidate device entries lightly; where invalidation is truly needed, assess the CHF 20-level re-registration fee before acting.

5. Verification checklist

• □ A change classification table exists, defining which changes fall into the 1-week reporting window
• □ The field list in the swissdamed Actors module is fixed, with a trigger mechanism and filing acknowledgements for field changes
• □ The CHRN application was completed before first placing on the market, without consuming the external processing time inside the 3-month window
• □ Assemblers of systems or procedure packs completed registration within 3 months under Art. 55(5)
• □ The device registration fee rules have been checked: data updates free, re-registration after invalidation requires a new fee
• □ Tier-one change filings are reconciled against the internal change ledger, traceable to specific dates

Legal information verified as of 29 October 2026.

GRZAN provides registration documentation and conformity file support for the Swiss market: CHRN application management, swissdamed Actors maintenance, change classification frameworks aligned with Art. 55 MedDO, and fee planning under FeeO-Swissmedic. Our team keeps your registrations on time and your costs predictable. For assistance, contact GRZAN at info@grzanglobal.com.