Your Easy Guide to Clinical Studies

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.

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)

Swiss Law

MedDO – see in particular articles

• Art. 3 Definition of medical devices and accessories
• Art. 5 References to European legislation