Pre-Market — Getting to Market

Sub-section	Covers
Classification	Rules 1–22 (MedDO) and 1–7 (IVDO), borderline products, legacy devices
General Safety & Performance Requirements	MedDO Annex I, GSPR checklist, SaMD, cybersecurity
Technical Documentation	Annex II/III content, SSCP, risk management, QMS
Conformity Assessment	Class I self-declaration, NB routes, EU NBs, DoC
Swissmedic Registration	DAPI, notification vs registration, CH REP duties, fees
Clinical Evidence	CER, ClinO-MD, BASEC, IVD performance evaluation
Special Device Types	Custom-made, sterile, SaMD, tissue, IVD companion diagnostics, combination products

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