A CE mark alone hasn't cleared Switzerland since 2021

A working agreement, then a gap with no patch

Before May 2021, the EU-Switzerland Mutual Recognition Agreement let a device conformity-assessed under EU rules move into the Swiss market and back without a separate Swiss review, treating the two markets as one for regulatory purposes. The update needed to keep that agreement current with the EU's new MDR was tied to a broader institutional framework negotiation between Switzerland and the EU, and when that broader negotiation broke down, the device-specific update never happened. The European Commission's own notice on the agreement's status makes the consequence explicit: Switzerland is now treated as a third country for medical devices, the same category the EU applies to any non-member state with no recognition arrangement in place at all.

Switzerland didn't loosen its rules; it duplicated them

What makes the Swiss case different from a market that simply falls back to its own weaker standard is that Switzerland's domestic ordinance, the Medical Devices Ordinance (MedDO), was already written to track the EU's substantive requirements, and stayed that way after the MRA lapsed. A device that meets MDR's general safety and performance requirements meets MedDO's nearly identical text. The lapse didn't create a new technical bar to clear — it created a second, separately administered gate in front of a bar that hadn't moved, with its own registration system and its own local representative requirement standing where the MRA used to make both unnecessary.

Article 51 asks for the same role Article 11 already created

MedDO Article 51 requires a foreign manufacturer with no Swiss establishment to appoint a Swiss authorised representative — a CH-REP — before placing a device on the Swiss market, and the duties that follow read like a close copy of the eight tasks MDR Article 11(3) already assigns an EU authorised representative: verifying the declaration of conformity and technical documentation exist, keeping copies available to the authority, meeting registration obligations, and carrying incident reports back to the manufacturer. A compliance file that already has an EU AR mandate built to Article 11's structure has most of the CH-REP mandate's content already drafted — it still has to be executed as a second, separate appointment, not inferred from the first one.

swissdamed is a parallel system, not a shared one

Registration runs through swissdamed, Swissmedic's own actor and device database, built in EUDAMED's image but administered independently of it. This blog has already covered how EUDAMED assigns a Single Registration Number per role under MDR Article 31; swissdamed does the same work for the Swiss market under MedDO Article 55, issuing its own Swiss Registration Number to the CH-REP within three months of a device first reaching the Swiss market. The two numbers look similar in function and answer to two different registries that don't read each other — an EU SRN carries no standing in swissdamed, and a manufacturer that assumes one registration covers both markets is tracking a merger that never happened.

The obligation runs in both directions

Because the lapse cuts the recognition both ways, a Swiss manufacturer selling into the EU now needs its own EU authorised representative under Article 11, just as an EU manufacturer selling into Switzerland needs a CH-REP under Article 51 — a reciprocal requirement neither side owed the other while the MRA still applied. A file that tracks only the direction its own business runs, EU-to-Switzerland or Switzerland-to-EU, is missing the fact that the same gap opened on both sides of the border at once.

A cross-border economic-operator tracker that carries the EU AR mandate and the Swiss CH-REP mandate as two distinct appointments, each registered in its own system and retained on its own decade-plus schedule, is previewed in the launch catalog. If your program handles the Swiss market differently, the shelf takes that correction directly.