Regulatory Framework Overview
Overview
Swiss medical device regulation uses a layered hierarchy: the TPA provides statutory authority; MedDO and IVDO contain the detailed technical requirements; Swissmedic guidance provides interpretive detail. The framework is closely aligned with EU MDR/IVDR.
The Regulatory Hierarchy
| Level | Instrument | Role |
|---|---|---|
| Primary law | TPA (SR 812.21) | Statutory authority, Swissmedic mandate, criminal penalties |
| Ordinance | MedDO (SR 812.213) | All technical requirements for medical devices |
| Ordinance | IVDO (SR 812.219) | All technical requirements for IVDs |
| Ordinance | ClinO-MD (SR 810.305) | Clinical investigations |
| Ordinance | Fees Ordinance (SR 812.213.1) | Registration fees |
| Guidance | Swissmedic guidance documents | Non-binding interpretive guidance |
| International | CH–EU MRA Chapter 4 | CE marking recognition conditions |
Relationship to EU MDR/IVDR
MedDO mirrors EU MDR 2017/745 in structure and substance; IVDO mirrors EU IVDR 2017/746. As a result:
- Classification rules, GSPR requirements, conformity assessment routes, and technical documentation requirements are substantively identical
- MDCG guidance generally applies in Switzerland — see MDCG Guidance Applicability
- CE certificates from EU-designated NBs form the basis for Swiss market access (subject to MRA)
- There are no Swiss-designated notified bodies. Manufacturers must designated under EU MDR/IVDR that are recognized in Switzerland under the MRA. use EU NBs
Swissmedic's Role
Swissmedic's pre-market role is primarily administrative (confirming registration completeness). Technical documentation is reviewed by EU NBs. Swissmedic's focus is market surveillance, vigilance management, and enforcement.
The MRA — Critical Variable
The CH–EU MRA Chapter 4 determines whether CE-marked devices need separate Swiss registration. See MRA with EU — Current Status.
Official Sources
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
Swissmedic
"For Class I devices, Swissmedic conducts a completeness check of the Declaration of Conformity and technical documentation. For Class IIa and above, technical documentation assessment is performed by EU-designated notified bodies (NBs) before Swiss registration. Swissmedic does not perform independent technical assessment but verifies that required documentation is present and that NB certification (where required) is valid under the MRA."