What is it? Why is it important?

The Medical Device Ordinance (MedDO) outlines the Swiss law on Medical Devices (MDs). The law applies to devices:

  • And its associated accessories (e.g. instruments, software, implants, reagents)
  • Without an intended medical purpose (e.g. contact lenses)
  • That are an integral part of a medicinal product (e.g. insulin pump)

Among others MedDO provides legislations on:

  • The definition and exception of what constitutes a device, with/without medical purpose
  • Requirements for putting a device on the market
  • Device classification, labelling and identification
  • Authorisation obligations
  • Post-market surveillance (e.g. incidents and actions)
  • Safety reporting obligations
  • Manufacturers, importers and distributors

The ordinance aligns with the EU MD Regulation (MDR) on classical MDs and active implantable MDs.

What do I need to do?

For studies with a MD, you are required to know and comply with requirements defined in the MedDO ordinance.

Based on your planned study:

  • Read the MedDO and familiarise yourself with the organization of the various chapters and sections
  • Focus on the articles that are relevant to your study. Tag them in order to ensure compliance
  • Based on the intervention know what risk category applies to your study (e.g. category A with low risk and category C with high risk)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Swiss Law

FEDLEX – law is available online under number

  • 812.213 MedDO

MedDO – see in particular articles

  • Art. 3 Definition of medical devices and accessories
  • Art. 5 References to European legislation
Abbreviations
  • CTU – Clinical Trials Unit
  • EU – European Union
  • FEDLEX – Publication Platform for Federal Laws
  • MD – Medical Device
  • MDR – Medical Device Regulation
  • MedDO – Medical Device Ordinance
Basic ↦ Ethics and Laws ↦ Medical Device Ordinance ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Medical Device Ordinance ↦ Aim

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