Par neatbilstībām 02.08.2005. MK noteikumos 581
Biedrība veicot analīzi ir konstatējusi, ka pašreiz pastāv situācija, ka dažādas iestādes un organizācijas interpretē MK noteikumus 581. savādāk un viedokļi krietni atšķiras. Šajā sakarā biedrība pieprasījusi skaidrojumu LR Ekonomikas ministrijai un Saeimas Juridiskajai komisijai par neskaidrībām piemērojot MK noteikumus 581. Precizēt - kāda inspicēšanas institūcija A, B vai C tipa drīkst veikt medicīnisko ierīču tehnisko uzraudzību saskaņā ar noteikumiem? LR Ekonomikas ministrija, atbildes vēstulē Biedrībai apstiprina, ka šāda situācija pastāv un norāda, ka MK noteikumi 581. neprecizē kāda tipa inspicēšanas institūcija drīkst veikt medicīnisko ierīču tehnisko uzraudzību, kas nozīmē, ka ikviena atbilstības novērtēšanas institūcija saņemot akreditāciju nacionālajā akreditācijas institūcijā kā inspicēšanas institūcija ir tiesīga inspicēt pašas vai tās vadošās organizācijas piegādātos produktus, ko lieto citas organizācijas. LR Ministru kabinets, pamatojoties uz Veselības ministrijas sagatavoto informāciju par MK not. 581 norāda, ka konkrēts akreditētas medicīnisko ierīču atbilstības inspicēšanas institūcijas tips noteikumos nav noteikts. Saskaņā ar to medicīnisko ierīču tehnisko uzraudzību ir tiesīga veikt akreditēta tehniskās uzraudzības iestāde. Biedrība uzskata, ka šāda noteikumu izpratne var veicināt interešu konfliktu rašanos, jo inspicēšanas institūcija šādā izpratnē nav trešā persona. Inspicēšanas institūcija nedrīkst būt tieši saistīta pārbaudāmo iekārtu izstrādē, konstruēšanā, tirdzniecībā vai tehniskajā apkopē, kā arī nedrīkst pārstāvēt puses kas iesaistītas šajās darbībās, tas varētu radīt potenciālus interešu konfliktus iekārtu inspicēšanas jomā, ka arī veicināt nekvalitatīva pakalpojuma sniegšanu.
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