After the MRA Chapter 4 Break: Switzerland as an EU Third Country

This article is number 04 in Volume 1, Regulatory Framework and Fundamentals, of the fifty-part series on medical device registration in Switzerland. Together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, article title and unique URL are listed in the table below.

1. Key takeaways

Chapter 4 of the Mutual Recognition Agreement has not been updated by the EU since May 2021, and Switzerland is therefore a third country vis-à-vis the EU. The chain reaction is four localisation obligations: foreign manufacturers must appoint a Swiss authorised representative (MedDO Art. 51(1)); economic operators must register and obtain a CHRN (Art. 55); devices must be registered in swissdamed (Art. 108, replacing the former notification obligation from 1 July 2026); and the CH-REP bears the fallback responsibility for vigilance reporting (Art. 66(2bis)). The EU CE mark itself remains accepted — the break does not mean redoing conformity assessment. The incremental work concentrates on entities and registers, not on technical files, and budgets should be allocated accordingly.

2. Legal basis

Verification entry points: the text of Chapter 4 of the Switzerland–EU Mutual Recognition Agreement (RS 0.946.526.81) and the Federal Council press release of 28 May 2026. Together they document both the current third-country status and the state of the ratification process, and they should be re-checked each quarter before any planning assumption about the package of agreements is updated.

3. Expert insights

1. The four obligations are not new barriers but the localisation of mutual recognition steps. Conclusion: while mutual recognition existed, the Swiss side could directly rely on EU-side conformity assessments and certain circulation information; once recognition broke, these steps shifted to local Swiss execution. The trade-off: the compliance increment concentrates on entities and registers — representation, CHRN, device registration and vigilance — not on technical assessment itself. Budgets focused on re-certification and redoing technical documentation are therefore misdirected and should be rebalanced toward registration workstreams.
2. The continued acceptance of the CE mark changes the cost structure. MedDO Art. 13(1) accepts the CE mark under EU MDR Annex V alongside the Swiss conformity mark under Annex 5. Conclusion: companies can carry over EU conformity assessment results, at the price of completing the Swiss chain of entities and registrations. The counterpoint: some companies have launched full re-certification projects because of the break; that investment does not match the statutory requirements and produces no additional legal benefit on the Swiss side.
3. The package of agreements of 2 March 2026 must not be cited as if in force. It contains a protocol amending the MRA and its annexes, which enters into force only after ratification by both sides: on the EU side, consent of the European Parliament and adoption by the Council; on the Swiss side, completion of the parliamentary process and an expected referendum. The industry expects entry into force no earlier than 2028 (practical estimate). Conclusion: signing and entry into force are two different events, and before entry into force the Chapter 4 status quo remains unchanged; planning around a coming abolition of the CH-REP and deferring representative appointments treats a non-effective document as a compliance basis.

4. Practical recommendations

1. Build the Swiss local responsibility chain on the third-country model, with no reserved exemptions for a non-effective agreement; base all planning on the provisions currently in force.
2. CHRN registration schedule: register within 3 months of first placing on the market, and report changes within 1 week (Art. 55(1)(2)).
3. Device registration schedule: the UDI Devices module is voluntary from 18 August 2025 until 30 June 2026, mandatory from 1 July 2026, with a transition period until 31 December 2026; devices requiring reports of serious incidents, FSCA or trends have no transition period from 1 July 2026.
4. State the fallback vigilance responsibility of the CH-REP in the mandate agreement (Art. 66(2bis)) and include written clauses on the transfer of that responsibility from the manufacturer to the representative.
5. Review the ratification progress of the package of agreements quarterly, but do not make project plans conditional on its outcome.

5. Verification checklist

• □ The foreign manufacturer has signed a written CH-REP mandate (Art. 51(1))
• □ CHRN registration is scheduled within 3 months of first placing and 1 week for changes
• □ swissdamed device registration is scheduled against the mandatory date of 1 July 2026
• □ The mandate agreement covers the vigilance and trend reporting fallback responsibility of the CH-REP
• □ Internal documents do not describe the package of agreements of 2 March 2026 as in force
• □ Liechtenstein entities, where applicable, have confirmed they must equally register with Swissmedic

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers and economic operators entering the Swiss market with end-to-end Swissmedic registration and compliance services, including third-country market entry mapping, CH-REP appointment and mandate drafting, CHRN and swissdamed registration scheduling, and quarterly monitoring of the ratification of the Switzerland–EU package of agreements. Our team keeps your Swiss obligations aligned with the law actually in force. For tailored guidance on your product portfolio, contact info@grzanglobal.com.