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 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.