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"Hankinnan kohteena on MDR 2017\/745 mukainen vaatimustenmukaisuuden arviointi luokan IIa laitteelle. Vaatimustenmukaisuuden arviointi toteutetaan liitteen IX mukaisena sis\u00e4lt\u00e4en sek\u00e4 laadunhallintaj\u00e4rjestelm\u00e4n ett\u00e4 teknisten asiakirjojen arvioinnin. Hankinta sis\u00e4lt\u00e4\u00e4 my\u00f6s sertifioidulle luokan IIa laitteelle suoritettavan valvonnan ja siihen kuuluvat arvioinnit.",
"",
"DigiFinland Oy toimii kansallisen Omaolo-palvelun valmistajana. Omaolo on t\u00e4ll\u00e4 hetkell\u00e4 luokiteltu ja rekister\u00f6ity l\u00e4\u00e4kint\u00e4laitedirektiivin mukaiseksi luokan I laitteeksi. ",
"",
"EU l\u00e4\u00e4kint\u00e4laiteasetuksen 2017\/745 (MDR) my\u00f6t\u00e4 Omaolo -palvelun luokittelu nousee luokkaan IIa, jonka johdosta palvelulle on suoritettava vaatimustenmukaisuuden arviointi.",
"",
"Ennen vaatimustenmukaisuuden arviointia Omaolo -palveluun ei voida tehd\u00e4 merkitt\u00e4vi\u00e4 muutoksia, mik\u00e4 aiheuttaa kiireen arvioinnille.",
"",
"Yhti\u00f6ll\u00e4 on sertifioitu ISO 13485-laatuj\u00e4rjestelm\u00e4. Dokumentaatio on laadittu suomen kielell\u00e4. Tavoitteena on saada Omaolo -palvelulle MDR vaatimustenmukaisuuden arviointi loppuvuodesta 2021. MDR sertifiointipalvelua tuottaa suomen kielell\u00e4 kaksi yhti\u00f6t\u00e4 SGS Fimko Ltd. sek\u00e4 Eurofins Expert Services Oy. Vaatimustenmukaisuuden arviointipalvelun saatavuus on t\u00e4ll\u00e4 hetkell\u00e4 eritt\u00e4in huono.",
"",
"MDR vaatimustenmukaisuuden arviointi perustuu hakemusmenettelyyn. Markkinavuoropuhelun perusteella mahdolliset laitokset (SGS Fimko Ltd. sek\u00e4 Eurofins Expert Services Oy) antavat palvelusta sitomattoman hinta-arvion. Hankinnan kokonaishintaa voidaan hakemusmenettelyss\u00e4 tarkentaa olennaisestikin. L\u00e4\u00e4kint\u00e4laiteasetuksen mukaan asiakas ei voi tehd\u00e4 samanaikaisesti kahta hakemusta.",
"",
"Edell\u00e4 mainitusta johtuen hankinnassa ei saada aikaiseksi hankintalaissa tarkoitettua kilpailua tai siihen liittyv\u00e4\u00e4 vertailua, johon hankinta voitaisiin perustaa.",
"",
""
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"L\u00e4\u00e4kint\u00e4laiteasetuksen mukainen sertifiointi perustuu hakemusmenettelyyn, jossa laitokset antavat hinta-arvion palvelusta. Hankinnan hinta t\u00e4smentyy hakemusmenettelyss\u00e4. L\u00e4\u00e4kint\u00e4laiteasetuksen mukaan asiakas ei voi tehd\u00e4 samanaikaisesti kahta hakemusta. ",
"",
"Hankinnassa ei saada aikaiseksi hankintalaissa tarkoitettua kilpailua eik\u00e4 tarjousten vertailua, johon hankinta voitaisiin perustaa.",
"",
"Hankintalain 40 \u00a7 mukainen suorahankinta. Hankintayksikk\u00f6 voi valita suorahankinnan, jos:",
"",
"2)\u2002teknisest\u00e4 tai yksinoikeuden suojaamiseen liittyv\u00e4st\u00e4 syyst\u00e4 vain tietty toimittaja voi toteuttaa hankinnan; lis\u00e4edellytyksen\u00e4 on, ett\u00e4 j\u00e4rkevi\u00e4 vaihtoehtoisia tai korvaavia ratkaisuja ei ole eik\u00e4 kilpailun puuttuminen johdu hankinnan ehtojen keinotekoisesta kaventamisesta.",
""
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