448
Meditsiiniseadme seaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus (pädevuse andmine Ravimiametile)
Introduced
3 June 2024
Last action
6 November 2024 · Accepted
Status
AVALDATUD_RIIGITEATAJAS
Sponsors
Eero Merilind, Vabariigi Valitsus
Subjects
Discovery layer
Source updated
6 November 2024
Summary
Eelnõu näeb ette viia meditsiiniseadmete valdkonnaga tegelemise pädevus Terviseametist Ravimiametisse. Meditsiiniseadmed on väga varieeruv ja suur rühm tooteid, mille kasutamine on igapäevane tervishoiuteenuse osutamisel kui ka väga paljudes kodudes. Meditsiiniseadmed on näiteks plaastrid, termomeetrid ja kiirtestid, aga ka keerukad süsteemid, mida kasutatakse tervishoiuasutustes. Samuti on meditsiiniseadmetena määratletavad mõned tarkvarad, mida kasutatakse tervishoius ja meditsiinilistest toimingutes. Kavandatud muudatuse eesmärk on valdkonda korrastada, et ülesandeid paremini täita. Praegu tegeleb meditsiiniseadmete valdkonnaga Terviseamet, mille peamine tegevusvaldkond on tervisekaitse- ja tervishoiuteenused. Ravimiameti peamine tegevusvaldkond on toodete (ravimid) ohutuse, kvaliteedi ja efektiivsuse tagamine. Kuna ravimid ja meditsiiniseadmed on mõlemad oma olemuselt ja Euroopa Liidu õiguse tähenduses tooted, on mõistlik, et nendega tegeleb sama asutus. Koos ülesannetega viiakse Ravimiametisse üle ka need ametnikud, kes seni on Terviseametis meditsiiniseadmete valdkonnaga tegelenud. Seega on tagatud ülesannete järjepidev täitmine. Lisaks antakse eelnõu kohaselt Ravimiametile õigus määratleda, milline toode on meditsiiniseade. Pädeva asutuse õigus teha otsuseid toodete meditsiiniseadmena määratlemise osas on oluline nii valdkondliku järelevalve teostamise vaates (näiteks olukorras, kus tootja on lasknud turule toote, mis vastab meditsiiniseadme definitsioonile, kuid mille osas tootja ise on võtnud eksliku seisukoha, et tegemist ei ole meditsiiniseadmega ning jätnud kohalduvad nõuded täitmata) kui ka selleks, et pädev asutus saaks anda ettevõtjatele vajaliku selguse nende toodete õigusliku staatuse osas (näiteks turule laskmisele eelnevas ehk arendamise etapis). Tervishoiuasutuste halduskoormuse vähendamiseks tunnistatakse kehtetuks kohustus esitada meditsiiniseadmete pädevale asutusele dokumente asutusesiseselt valmistatavate ja kasutatavate seadmete kohta. Sellised seadmed on kõige sagedamini laboratoorseteks analüüsideks kasutatavad vahendid (näiteks DNA analüüs asutusesiseselt välja töötatud metoodikaga), kuid võivad olla ka erinevad tarkvaralised lahendused (näiteks otsustustugi tervishoiuteenuse osutajale) ja ka muud vahendid, mida tervishoiuasutus kasutab meditsiinilisel otstarbel, kuid mida nad ei ole saanud nõuetele vastavana turult hankida. Selleks, et tagada ka nende seadmete puhul ohutus ja toimivus, tuleb tervishoiuasutustel täita ELi määrustes esitatud tingimused, sh koostada valdava osa seadmete kohta nende tootmist ning omadusi kirjeldav dokumentatsioon. Kehtiv seadus kohustab dokumentatsiooni esitama pädevale asutusele. Eelnõuga muudetakse seda kohustust nii, et tervishoiuasutus esitab pädevale asutusele selliste meditsiiniseadmete loetelu, kes küsib täiendavaid andmeid ja dokumente üksnes vajaduse korral. Samuti antakse eelnõu kohaselt Terviseametile juurdepääs tervise infosüsteemile juhul, kui amet teostab riiklikku ja haldusjärelevalvet. Ka praegu on ametil õigus andmeid töödelda, kuid seda on turvalisem teha, kui on otsejuurdepääs andmetele. Praegu saadakse andmed krüpteeritult, kuid andmekogus enda töötlus on turvalisem. Eelnõuga kavandatud muudatused mõjutavad vähesel määral meditsiiniseadmete tootjaid ja kasutajaid. Eelkõige tuleb kohaneda teise asutuse poole pöördumisega, kuid pakutav teenus jääb samaks. Meditsiiniseadmete andmekogu alusel on Eestis ligikaudu 200 meditsiiniseadmete tootjat ja 650 levitajat.
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Timeline
3 June 2024
AVALDATUD_RIIGITEATAJAS
Source: SE
6 November 2024
Accepted
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Documents
26 official files
Lõpptekst
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Lõpptekst
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Vabariigi Presidendi otsus pdf
pdf · ET · 13 November 2024
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Vastuvõetud seadus asice
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docx · ET · 21 October 2024
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Sponsors
- Eero Merilind · plenary-member
- Vabariigi Valitsus · Vabariigi Valitsus · Initiator
Related records
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Related across the Repo ecosystem
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Direct relationships
- Legal framework · Meditsiiniseadme seaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus (pädevuse andmine Ravimiametile) · 448 · EE
- Identifier matchPROJECTS_FROM
Same estonia record 7bc329c3-f351-44bb-aed6-30c8dadc5759 projected from PoliticalRepo EE row.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.riigikogu.ee/tegevus/eelnoud/7bc329c3-f351-44bb-aed6-30c8dadc5759/
- Open data entity: https://api.riigikogu.ee/api/volumes/7bc329c3-f351-44bb-aed6-30c8dadc5759
- estonia · 7bc329c3-f351-44bb-aed6-30c8dadc5759 · source updated 6 November 2024