Glossary of Key Terms
| Term | Definition |
|---|---|
| BASEC | Swiss association of research ethics committees. Coordinates ethics review for clinical investigations under ClinO-MD. |
| CH REP | Swiss Authorised Representative. Person/entity established in Switzerland mandated by a non-Swiss manufacturer to perform regulatory obligations. Basis: MedDO Art. 56–59. |
| ClinO-MD | Clinical Investigations Ordinance for Medical Devices (SR 810.305). Governs clinical investigations of medical devices in Switzerland. |
| DAPI | Swissmedic's product database of authorised therapeutic products. Swiss market registration/notification occurs through DAPI at dapi.ch. |
| DoC | Declaration of Conformity. Formal document in which the manufacturer declares the device meets all applicable MedDO/IVDO requirements. |
| FSCA | Field Safety Corrective Action. Any action by the manufacturer to reduce the risk of death or serious health deterioration associated with a marketed device. |
| FSN | Field Safety Notice. Communication to customers as part of an FSCA. |
| GSPR | General Safety and Performance Requirements. Essential requirements in MedDO Annex I and IVDO Annex I that all devices must meet. |
| IVDO | IVD Ordinance (SR 812.219). Swiss regulation for in vitro diagnostic devices; mirrors EU IVDR 2017/746. |
| MedDO | Medical Device Ordinance (SR 812.213). Primary Swiss regulation for medical devices; mirrors EU MDR 2017/745. In force 26 May 2021. |
| METAS | Federal Institute of Metrology. Relevant for measuring function devices (Class Im). |
| MRA | Mutual Recognition Agreement between Switzerland and the EU. Chapter 4 covers medical devices; its operational status determines whether CE marking is sufficient for Swiss market access. |
| NB | Notified Body. EU-designated third-party conformity assessment body. Switzerland uses EU NBs — there are no Swiss-designated NBs. |
| PMCF | Post-Market Clinical Follow-Up. Ongoing process collecting clinical data from post-market device use. |
| PMPF | Post-Market Performance Follow-Up. IVD equivalent of PMCF under IVDO. |
| PMS | Post-Market Surveillance. Systematic process of proactively collecting and analysing post-market use data. |
| PSUR | Periodic Safety Update Report. Periodic PMS summary for Class IIa, IIb, and III devices. |
| QMS | Quality Management System. ISO 13485 is the applicable standard for medical device manufacturers. |
| SSCP | Summary of Safety and Clinical Performance. Publicly available document required for Class III and implantable devices. |
| TPA | Therapeutic Products Act (Heilmittelgesetz, SR 812.21). Umbrella Swiss law covering all therapeutic products including medical devices. |
| UDI | Unique Device Identification. Numeric/alphanumeric series allowing unambiguous identification of specific devices. |
Official Sources
Disclaimer
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.