Medical Devices Ordinance (MedDO) at a Glance
Short answer
The MedDO governs medical devices in Switzerland. It is modelled in content on the EU MDR but is autonomous Swiss law. For foreign manufacturers, the key obligation is naming an authorised representative in Switzerland, the so-called CH-REP.
How does the MedDO relate to the EU MDR?
The MedDO adopts the EU MDR's system: the same classification rules, the same general safety and performance requirements, the same conformity assessment procedures. Legally, however, it is autonomous. Because the Mutual Recognition Agreement for medical devices has not been updated, Switzerland counts as a third country from the EU's perspective.
| Scenario | Requirement | Note |
|---|---|---|
| EU manufacturer supplies into Switzerland | CH-REP required | Registration with Swissmedic |
| Swiss manufacturer supplies into the EU | EU authorised representative required | EC-REP under the MDR |
| Certificates from EU notified bodies | recognised in Switzerland | Basis: MedDO |
| Swiss importer | own duties and registration | Labelling required |
| Distributor | checking duties on receipt | Documentation needed |
What is the CH-REP and who needs one?
The CH-REP is the authorised representative established in Switzerland for a manufacturer based abroad. They keep the technical documentation available, act as Swissmedic's point of contact, take part in vigilance reporting and recalls, and are subsidiarily liable for defective products.
- Mandatory for every manufacturer with no Swiss establishment whose products are placed on the market here.
- A written mandate setting out tasks and responsibilities.
- Technical documentation and the declaration of conformity must be available.
- Stated on the product, the packaging or the instructions for use.
- Involvement in field safety corrective actions and vigilance reporting.
How are medical devices classified?
By risk, into classes I, IIa, IIb and III; for in vitro diagnostics, into A, B, C and D. The class determines whether a notified body must be involved. The manufacturer can carry out the conformity assessment itself for class I devices with no measuring function and no sterility.
| Class | Example | Notified body |
|---|---|---|
| I | Dressings, walking aids | no |
| I sterile or with a measuring function | sterile compresses, clinical thermometers | yes, for the relevant aspect |
| IIa | Hearing aids, dental fillings | yes |
| IIb | Ventilators, infusion pumps | yes |
| III | Implants, stents | yes, with extended assessment |
Where can you find more on the CH-REP and the MedDO?
This guide is a short overview for readers coming from medicinal products law. The full picture on the CH-REP, importer duties, swissdamed and UDI is available on our partner site in the Swiss regulatory network, ch-rep-finder.ch.
Frequently asked questions
Do medical devices need a Swissmedic authorisation?
No. They need a conformity assessment and, from class IIa, the involvement of a notified body. Swissmedic supervises the market but does not grant product authorisations.
Who must name a CH-REP?
Every manufacturer with no Swiss establishment whose products are placed on the market in Switzerland. The duty applies regardless of the risk class.
Are CE certificates recognised in Switzerland?
Yes. The MedDO recognises certificates from EU notified bodies. Conversely, the EU has not automatically recognised Swiss conformity assessments since the MDR took effect.
What is swissdamed?
The Swiss database for medical devices, recording economic operators and products. It is the Swiss counterpart to EUDAMED.
Does the MedDO also apply to in vitro diagnostics?
No, they are governed by the separate Ordinance on In Vitro Diagnostic Medical Devices (IvDV), modelled on the EU IVDR.
Sources
- Fedlex SR 812.213 Medical Devices Ordinance (MedDO)
- Swissmedic: Medical Devices
- CH-REP Finder (partner site)
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