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 in accordance with Annex 1 MedDO (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
  • Conformity assessment
  • 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

MedDO – see in particular articles

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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

Please note: the Easy-GCS tool is currently under construction.