Estonia medical device regulations

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).

Estonia is an EU member State, so Regulation (EU) 2017/745 applies directly and sits above the Meditsiiniseadme seadus, which supplies the national competent authority, the market-notification duties and the supervision regime: section 1(2) of the Act disapplies it where the Regulation applies, and section 14¹ makes Ravimiamet the competent authority and the authority responsible for notified bodies. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Estonian metadata view onto it and opens the provisions the Act hooks into: in-house manufacture (Art. 5), manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14), the implant card the Act requires the manufacturer and the health-care provider to handle in Estonian (Art. 18), the EUDAMED registration of economic operators and devices that Art. 30(2) lets Estonia keep a national notification step alongside and whose full functionality Art. 123(3) conditions (Arts. 30 and 31, with Art. 123), the conformity-assessment-body designation the Act charges Ravimiamet with (Art. 38) and vigilance (Art. 87). It is not a second corpus copy.

Union instrument, expressed once in eu.ts as eu-regulation-2023-607. This Estonian row is a metadata view onto that expression. It matters to Estonia because the transitional periods it set for devices covered by a valid Directive 90/385/EEC or 93/42/EEC certificate (Article 120(3a) to (3f) MDR), and the corresponding IVDR period in Article 110(4), determine how long those certificates remain a route into the Estonian market and how long the Act’s implementing provisions for them have to run. It is not a second corpus copy.