701
Meditsiiniseadme seaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus
Introduced
29 September 2022
Last action
7 December 2022 · Accepted
Status
AVALDATUD_RIIGITEATAJAS
Sponsors
Helmen Kütt, Vabariigi Valitsus
Subjects
Discovery layer
Source updated
7 December 2022
Summary
Eelnõuga tunnistatakse meditsiiniseadme seaduses kehtetuks sätted, mis alates 26. maist kuuluvad ELi määruste reguleerimisalasse, kuna ELi õigusega on loodud meditsiiniseadmete regulatsiooni uus raamistik ja kehtetuks tunnistatud valdkonda seni reguleerinud direktiivid. ELi määrustega on kehtestatud meditsiiniseadmete suhtes ELis ühtlustatud ja senisest rangemad kvaliteedi- ja ohutusnõuded, et lahendada selliste seadmetega seotud üldisi ohutusprobleeme. Eelnõus esitatud muudatuste eesmärk on täpsustada ettevõtjate, meditsiiniseadme kasutajate ja Terviseameti õigusi ja ülesandeid ELi määruste rakendamisel. Eelnõuga tehtavad muudatused puudutavad meditsiiniseadme kasutajaid (tavakasutajad ja professionaalsed kasutajad), ettevõtjaid (sponsorid, tootjad ja nende volitatud esindajad, importijad ja levitajad) ja riigiasutusi (Terviseamet ja Ravimiamet). Eelnõuga lisatakse levitajatele kohustus teatada meditsiiniseadmete süsteemi, protseduuripaketi või suurema riskiga in vitro diagnostikameditsiiniseadme esmakordsest levitamisest Eestis, millega kaasneb ettevõtjatele täiendav halduskoormus, kuid aitab saavutada parema turuülevaate Eesti turul olevatest meditsiiniseadmetest ning tõhustada turujärelevalvet, et Terviseamet saaks tuvastada Eesti turul nõuetele mittevastavaid (sh võltsitud või ohtlikke) meditsiiniseadmeid ja need vajadusel turult eemaldada.
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Timeline
29 September 2022
AVALDATUD_RIIGITEATAJAS
Source: SE
7 December 2022
Accepted
Votes
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Documents
32 official files
Lõpptekst
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Lõpptekst
docx · ET · 15 December 2022
Lõpptekst asice
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Vabariigi Presidendi otsus
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Vabariigi Presidendi otsus asice
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Vastuvõetud seadus asice
asice · ET · 7 December 2022
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Kaaskiri Vabariigi Presidendile
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Vastuvõetud seadus
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Eelnõu
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Seletuskiri
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Muudatusettepanekute loetelu
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Eelnõu
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Seletuskirja lisa 4 (kooskõlastustabel)
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Seletuskirja lisa 3 (rakendusaktide kavandid)
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Seletuskirja lisa 2 (vastavustabel)
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Seletuskirja lisa 1 (kulude kalkulatsioon)
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EIS teade
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Sponsors
- Helmen Kütt · plenary-member
- Vabariigi Valitsus · Vabariigi Valitsus · Initiator
Related records
No cross-record relationships stored yet.
Related across the Repo ecosystem
Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.
Direct relationships
- Legal framework · Meditsiiniseadme seaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus · 701 · EE
- Identifier matchPROJECTS_FROM
Same estonia record 8173d025-6c81-4f51-8fe4-a94801ecada3 projected from PoliticalRepo EE row.
Meditsiiniseadme seaduse muutmise ja sellega seonduvalt teiste seaduste muutmise seadus
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.riigikogu.ee/tegevus/eelnoud/8173d025-6c81-4f51-8fe4-a94801ecada3/
- Open data entity: https://api.riigikogu.ee/api/volumes/8173d025-6c81-4f51-8fe4-a94801ecada3
- estonia · 8173d025-6c81-4f51-8fe4-a94801ecada3 · source updated 7 December 2022