Holding Technical Documentation: CH-REP Custody or Direct Submission to Swissmedic

This article is issue 22 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

In Switzerland, technical documentation must be handled as two separate questions: who holds it, and who submits it. MedDO Art. 51(3) points the rights, duties and scope of the CH-REP mandate to Article 11 of the EU MDR, and Article 11(3) of the EU MDR requires the authorised representative to keep a copy of the technical documentation available — that is the holding duty. Art. 51(3bis) allows the manufacturer and the CH-REP to agree that the manufacturer submits the documentation directly to Swissmedic upon request, while the CH-REP must ensure the submission is completed within 7 days — that is the submission arrangement. The two are not alternatives. The direct-submission agreement only solves the submission route; it does not lift the representative’s obligation to hold a copy. Reading (3bis) as permission to withhold a copy from the CH-REP is the most expensive misreading in this provision set.

2. Legal basis

3. Expert insights

1. The 7-day period is a performance deadline, not a negotiating margin. The text structure of Art. 51(3bis) is that the parties may agree on direct submission by the manufacturer, and the CH-REP must ensure submission within 7 days. The responsible party remains the CH-REP; the manufacturer acts as a performance assistant. This design actually favours the manufacturer: the technical documentation does not have to reside permanently with a third party across borders, so the exposure of intellectual property is smaller. The price is that the CH-REP carries an uncontrolled third-party performance risk — it cannot, by its own capability, deliver within 7 days a file it does not hold. The typical hedge seen in the market is therefore a two-track arrangement: the representative holds a complete copy (satisfying Article 11(3)), while the agreed primary submission route is direct delivery by the manufacturer (satisfying (3bis)).

2. A copy-only arrangement will get stuck on version consistency. Having the CH-REP retain a copy looks safest, but a copy inherently lags behind the manufacturer’s version iteration. What Swissmedic requests under the Art. 51 procedures is usually the currently valid version, and an outdated copy in the representative’s hands becomes a ground for correction requests. The trade-off is this: the value of a copy is constant deliverability, while the value of direct submission is that the version is always correct. If only the copy route is chosen, version synchronisation must be turned into a documented process with a defined frequency and acknowledgements of receipt; otherwise the copy degrades into an expired formal document (practical estimate).

3. The practical constraints on entities outside Switzerland are underestimated. When the manufacturer is located outside Switzerland, a Swissmedic request arriving at the CH-REP must still be relayed across borders to the manufacturer, through time zones, languages (the Swiss official languages being German, French and Italian) and internal approval chains. After these losses are deducted from the 7 days, the time left for the technical team to compile and translate the documentation is tight. One workable hedge is to write a response plan for Swissmedic requests into an annex of the mandate: name the contact person, the deputy contact, the response tiers and the delivery format of the documentation, so that nobody has to be found at the last minute.

4. Practical recommendations

1. In the written mandate, agree on both items at once: the CH-REP continuously holds a copy of the current version of the technical documentation (corresponding to Article 11(3) of the EU MDR), and the primary route for responding to requests is direct submission by the manufacturer (corresponding to Art. 51(3bis)).
2. Back-plan the 7 days into internal deadlines: confirm receipt on day 0, lock the version on day 2, complete document assembly on day 4, complete internal review on day 6, and reserve one day of buffer.
3. The mandate must state the language requirements for the technical documentation and which party bears translation responsibility; the three Swiss official languages are German, French and Italian, and unclear language responsibility will directly consume the 7 days.
4. Maintain a version synchronisation ledger: on every documentation revision, push the new version to the CH-REP and retain the acknowledgement of receipt.
5. If the manufacturer has already delegated vigilance reporting duties to the CH-REP under Art. 66(2bis), the access rights to the technical documentation should be granted in the same mandate document, so the two documents do not conflict on permissions.

5. Verification checklist

• □ The mandate covers both holding a copy and direct submission within 7 days, rather than one of the two
• □ The starting point of the 7 days and the internal back-planned deadlines are defined, with a primary owner and a deputy named
• □ The language of the technical documentation and the translation responsibility are stated in the mandate
• □ The copy held by the CH-REP matches the manufacturer’s current version, with push acknowledgements retained
• □ The request response plan exists as an annex to the mandate, including contacts and delivery format
• □ Where vigilance duties are delegated, access to the technical documentation is authorised in the same document

Legal information verified as of 29 October 2026.

GRZAN provides manufacturers with registration documentation and conformity file support for the Swiss market: CH-REP mandate drafting covering technical documentation custody and 7-day direct submission, version synchronisation processes, and Swissmedic request response planning. Our team keeps your documentation chain deliverable within the statutory deadlines. For assistance, contact GRZAN at info@grzanglobal.com.