Residual notification scenarios: custom-made, in-house, repackaged and relabelled devices

This article is the 37th instalment of Volume 4, License-holder Import and Fees, of the Swiss Medical Device Registration 50-Article Series. Together with the remaining nine articles of this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below, so that readers can cite this article unambiguously and locate its companion pieces.

1. Key takeaways

From 1 July 2026, Art. 108 replaces the former notification duty with device registration in swissdamed, yet three scenarios remain on the notification channel: custom-made devices (Art. 19, form BW630_30_026e_FO, version 26.05.2021); in-house devices of health institutions (Art. 18, form BW630_30_027e_FO, version 26.05.2021); and repackaging and relabelling by importers or distributors (Art. 53(4) and Art. 54(4) combined with EU MDR Art. 16(3)(4), form BW630_30_025e_FO, version 26.05.2021). From 1 January 2027, Swissmedic accepts only unit-by-unit notifications, with custom-made devices excepted. Companies that carry over the old habit of notifying every product will therefore run two parallel tracks unnecessarily, while companies that overlook the residual scenarios will find themselves operating outside the system entirely on exactly the categories where no registration record exists to fall back on.

The classification work behind this article is small but consequential: one decision per product line determines the whole compliance route. Custom-made devices and in-house devices of health institutions stay event-based, while repackaging and relabelling obligations follow the activity and the entity performing it, which makes them recurring duties rather than one-time filings.

2. Legal basis

3. Expert insights

1. What remains on the notification channel is not an omission but structural non-applicability. Art. 108 covers the registration of devices, systems and procedure packs in swissdamed; custom-made devices and in-house devices of health institutions do not, at the time of placing on the market, carry the regular UDI-DI/Basic UDI-DI structure needed for unified registration, and Art. 13(2) additionally states that these two categories must not bear a conformity mark. The legislative trade-off separates registration by product from notification by event: whatever can enter the UDI Devices module is registered, and what cannot is kept as a single-item notification. The basis lies in the wording of the provisions themselves — Art. 18 and Art. 19 use the term notification.

1. Repackaging and relabelling notifications cover the activity, not the product. Art. 53(4) and Art. 54(4), combined with EU MDR Art. 16(3)(4), allow importers and distributors to translate product information, repackage or relabel, but a notification to Swissmedic is required before placing on the market. This duty attaches to the entity performing the activity and to the activity itself, not to any particular device item — a change of products or of packaging sizes by the same entity can each trigger a fresh notification. The opposing reading, that a single notification suffices when the activity is first started, does not match the wording requiring notification before each placing on the market.

1. Repackaging and relabelling also carry a precondition that is easily overlooked. The quality system of whoever performs these activities must be audited and certified by a designated body. This is not a condition crossed by simply filing form BW630_30_025e_FO; it is a qualification threshold. Companies routinely underestimate this item and treat the notification as the only compliance action. From 1 January 2027, only unit-by-unit notifications are accepted (custom-made devices excepted), a change that narrows the channel further to one item per report, with batch summaries no longer accepted.

4. Practical recommendations

1. First classify the scenario: products that can carry a UDI-DI go through swissdamed registration in every case, and only custom-made devices, in-house devices of health institutions, and repackaging/relabelling stay on notification — do not carry over the old habit of notifying all products.
2. Use the corresponding current form: custom-made devices use BW630_30_026e_FO, in-house devices use BW630_30_027e_FO, and repackaging or relabelling uses BW630_30_025e_FO, all at version 26.05.2021; check whether a newer version exists before each submission.
3. Entities performing repackaging or relabelling should first secure the audit and certification of their quality system by a designated body, and only then start the activity.
4. Adapt internal processes to the unit-by-unit notification requirement from 1 January 2027: prepare and submit per item, with no reliance on batch lists (custom-made devices excepted).
5. Where notification and registration run in parallel, keep separate ledgers for each track, so that the same device never shows conflicting statuses on the two channels.

5. Verification checklist

• □ The registration start of 1 July 2026 and the three residual notification scenarios have been confirmed
• □ Custom-made devices use form BW630_30_026e_FO (26.05.2021)
• □ In-house devices of health institutions use form BW630_30_027e_FO (26.05.2021)
• □ Repackaging/relabelling uses form BW630_30_025e_FO (26.05.2021)
• □ The quality system of the repackaging/relabelling entity has been audited and certified by a designated body
• □ Submission processes have been adapted to unit-by-unit notification from 1 January 2027 (custom-made devices excepted)

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For the residual notification scenarios GRZAN provides Swiss authorized representative (CH-REP) services, classifies each product line between swissdamed registration and the remaining notification channel, prepares the correct Swissmedic forms, and supports repackaging and relabelling entities in securing quality-system certification by a designated body, alongside fee budget models covering registration fees and hourly-based charges. For CH-REP appointment, notification management or fee budgeting support for the Swiss market, contact info@grzanglobal.com.