Medical Device Ordinance (MedDO)
Overview
The Medical Device Ordinance (Medizinprodukteverordnung, MedDO / SR 812.213) is the primary Swiss regulation for medical devices. It entered into force on 26 May 2021 and replaced the predecessor MDD-implementing ordinance. MedDO mirrors EU MDR 2017/745 in structure and technical requirements.
MedDO Structure
| Chapter | Content |
|---|---|
| Chapter 1 (Art. 1–3) | Scope, purpose, definitions |
| Chapter 2 (Art. 4–18) | Obligations of economic operators (manufacturer, CH REP, importer, distributor) |
| Chapter 3 (Art. 19–28) | Identification, traceability, registration |
| Chapter 4 (Art. 29–32) | UDI system |
| Chapter 5 (Art. 33–51) | Clinical investigations |
| Chapter 6 (Art. 52–55) | Notification and registration with Swissmedic |
| Chapter 7 (Art. 56–59) | Swiss Authorised Representative (CH REP) |
| Chapter 8 (Art. 60–75) | Post-market surveillance and vigilance |
| Chapter 9 (Art. 76–100) | Market surveillance and Swissmedic powers |
| Chapter 10 (Art. 101–113) | Final and transitional provisions |
MedDO Annexes
| Annex | Content |
|---|---|
| Annex I | General Safety and Performance Requirements (GSPRs) |
| Annex II | Technical documentation — general |
| Annex III | Technical documentation — post-market follow-up |
| Annex IV | Declaration of Conformity |
| Annex V | CE marking |
| Annex VI | Information to be submitted upon registration |
| Annex VII | Requirements to be met by conformity assessment bodies |
| Annex VIII | Classification rules |
| Annex IX | Conformity assessment based on QMS |
| Annex X | Conformity assessment based on type examination |
| Annex XI | Conformity assessment based on product conformity verification |
| Annex XII | Certificates issued by a conformity assessment body |
| Annex XIII | Procedure for custom-made devices |
| Annex XIV | Clinical evaluation and PMCF |
| Annex XV | Clinical investigations |
| Annex XVI | List of devices without a medical purpose (requires MedDO compliance) |
Official Sources
Disclaimer
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