RT I, 12.07.2025, 23

Meditsiiniseadme seadus, ingested as the terviktekst (consolidated text) at Riigi Teataja publication reference RT I, 12.07.2025, 23, whose wording took effect on 1 October 2025. The Act was originally adopted on 13 October 2004 and first entered into force on 1 December 2004 (RT I 2004, 75, 520); the consolidated text carries the whole amendment history inline as Riigi Teataja amendment markers, which are retained in the extract as provenance. Eleven chapters — üldsätted (general provisions); placing on the market and putting into use; professional use; sale on the basis of a medical device card; the free sale certificate; devices manufactured in-house; implantable devices; acting as a conformity assessment body; state and administrative supervision; liability; and implementing provisions — with forty-two numbered sections (§§ 1–41 and § 47) plus the superscript-inserted sections, 68 article blocks in all. Section 1(2) disapplies the Act where Regulations (EU) 2017/745 or 2017/746 apply; section 14¹ makes Ravimiamet the competent authority and the authority responsible for notified bodies, and the same provision gives it the power to define a product as a medical device. The triage row recorded that this wording's validity ends on 30 September 2026, i.e. that a further amendment takes effect on 1 October 2026; that date is recorded here as a currentness observation, and the version ingested is the one in force on the verification date. The instrument is enacted by the Riigikogu; Ravimiamet is the authority it charges with supervision, save that supervision of the professional-use chapter belongs to Terviseamet (the Health Board).

RT I, 12.07.2025, 23 is the official identifier SAM uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.