Signing the CH-REP mandate: written authorisation and scope under Art. 51

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the twelfth 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 mandate letter is the single gateway document for access to the Swiss market: without a written mandate, the devices of a manufacturer located outside Switzerland may not be placed on the market, and the subsequent CHRN and swissdamed registrations cannot proceed at all. The mandate must simultaneously cover three elements — the placing-on-the-market-related formal and safety matters under Art. 51(2), the rights and obligations and the scope of the mandate as determined under Article 11 of the EU MDR, and a written agreement on whether the vigilance reporting responsibilities under Art. 66(2bis) are transferred to the CH-REP. Any of the three elements being missing exposes the manufacturer to the same blocking outcome, because importers and distributors are themselves obliged to verify that the mandate exists and covers what the law requires before they may handle the devices.

2. Legal basis

3. Expert insights

1. Written form is a legal requirement, not an evidentiary recommendation. The wording of Art. 51(1) is that the CH-REP must be designated by written mandate; the negative consequence is that otherwise the devices may not be placed on the market. An oral arrangement or a framework agreement does not constitute a mandate. When an importer verifies under Art. 53(1)(c) that a CH-REP has been designated in accordance with Art. 51, the absence of a written mandate letter on file means the conclusion must be that the devices may not be placed on the market.
2. The statutory minimum scope is set by Art. 51(2); the ceiling is set by Article 11 of the EU MDR. Art. 51(2) limits the CH-REP to placing-on-the-market-related formal and safety matters, and Art. 51(3) then points to Article 11 of the EU MDR to determine the rights and obligations and the scope of the mandate. A common error in practice is the reverse one: writing commercial agency, warehousing and logistics into the mandate letter. These fall outside the statutory scope, and including them only saddles the CH-REP with contractual liability without any regulatory basis.
3. The 7-day arrangement of Art. 51(3bis) must be actively chosen in the mandate. This provision allows the manufacturer and the CH-REP to agree that the manufacturer will submit technical documentation directly to Swissmedic upon request, but the CH-REP must still ensure submission within 7 days. The provision was inserted by the ordinance of 19 May 2021 and entered into force on 26 May 2021 (AS 2021 281). It is an optional Swiss-specific arrangement with no equivalent in the EU framework; unless expressly stated in the mandate letter, it does not apply.
4. The legal consequences of a change of representative follow Article 12 of the EU MDR (Art. 51(4)), and the transition windows have closed. Art. 104a once staged the deadlines: Class III devices, implantable Class IIb devices and active implantable devices by 31 December 2021; non-implantable Class IIb and Class IIa devices by 31 March 2022; Class I devices and systems and procedure packs by 31 July 2022; and, in addition, a transition until 31 July 2023 for indicating the representative in the accompanying documents instead of on the label. All of these deadlines have expired, which means there is no longer any room to place devices on the market first and complete the mandate afterwards; a change of representative, too, must be executed seamlessly.

4. Practical recommendations

1. Execute the mandate as a written original (with signature page and effective date), and define the device list or product family scope explicitly, avoiding vague formulations that purport to cover all future products in one sweep.
2. Add a dedicated clause stating whether the direct submission arrangement of Art. 51(3bis) is agreed; if it is, specify the starting point of the 7-day period and the designated contacts on both sides.
3. Add a further clause stating whether the serious incident, FSCA and trend reporting responsibilities under Art. 66(2bis) are transferred to the CH-REP; absent a written agreement, no transfer takes place.
4. Handle a change of representative under Article 12 of the EU MDR, and update in parallel the registration information under Art. 55(2) (changes reported within 1 week) and the representative information shown on the accompanying documents of the products.
5. Require the CH-REP to provide evidence of its quality system (with ISO 13485 as one of the baselines) and a description of its PRRC set-up, completing the due diligence on the representative before signature.

5. Verification checklist

• □ The mandate letter is a written original containing a signature page, effective date and a device scope list.
• □ The mandate scope covers the formal and safety matters of Art. 51(2), without mixing in non-statutory matters such as commercial agency.
• □ The choice on the Art. 51(3bis) direct submission arrangement has been made explicit, together with the mechanism for meeting the 7-day deadline.
• □ A written agreement exists on whether vigilance responsibilities under Art. 66(2bis) transfer to the CH-REP.
• □ The change-of-representative procedure incorporates Article 12 of the EU MDR and the 1-week reporting deadline of Art. 55(2).
• □ The quality system evidence of the CH-REP (ISO 13485 and similar) and the PRRC qualification documents are archived and available for inspection.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway design and classification strategy, including drafting and reviewing CH-REP mandate letters that correctly scope Art. 51(2) duties, the Art. 51(3bis) option and vigilance transfers. For support with your Swiss mandate architecture, contact GRZAN at info@grzanglobal.com.