Regulation (EU) 2017/745

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.

Regulation (EU) 2017/745 is the official identifier SAM uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.