CH
The class transfers from the EU exactly. What does not transfer is market access — and that is the part that catches manufacturers out.
Switzerland is the one market on this site where the classification question has a short answer: the Swiss Medical Devices Ordinance mirrors the MDR classification rules, so a device that is Class IIb in the EU is Class IIb in Switzerland. Which means the interesting problem is not classification at all. Since mutual recognition with the EU lapsed, Switzerland has been a third country for medical device purposes: a Swiss authorised representative is required, along with Swiss-specific labelling and importer obligations. A manufacturer who solves classification and assumes the rest follows from the CE mark has solved the easy half.
One to one with the EU MDR. This is the only market here where mapping the class across the border is not a mistake — and precisely because of that, it is the market where the real work lies somewhere other than in the class.
NOTE —
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | Low | As per MDR |
| IIa | Medium | As per MDR |
| IIb | Medium-high | As per MDR |
| III | High | As per MDR |
Yes. The Swiss Medical Devices Ordinance mirrors the MDR classification rules, so the class is the same. Market access requirements are not the same.
A manufacturer outside Switzerland requires a Swiss authorised representative, together with Swiss-specific labelling. This follows from Switzerland being treated as a third country since mutual recognition with the EU lapsed, and is independent of the device's class.
The questionnaire classifies under the EU MDR and reports the Switzerland class alongside it, with the rules that produced each. Tick this market when you start.
