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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
MedDO – see in particular articles
- Art. 3 Definition of medical devices and accessories
- Art. 5 References to European legislation