Svondo rino takaita dzidziso pamusoro pemitemo yeMDR.Hitec Medical iri kunyorera MDR CE chitupa uye fungidzira kuti uchachiwana Chivabvu anotevera.

Takadzidza nezvekuvandudza maitiro emitemo yeMDR.

Musi wa5 Chivabvu 2017, The Official Journal yeEuropean Union yakaburitsa zviri pamutemo EU Medical Device Regulation (MDR) 2017/745.

Chinangwa chemutemo uyu ndechekuona kuchengetedzwa kurinani kwehutano hweveruzhinji uye kuchengetedzwa kwemurwere.MDR ichatsiva Directives 90/385/EEC (Active Implantable Medical Device Directive) uye 93/42/EEC (Medical Device Directive).Zvinoenderana nezvinodiwa zveMDR Chinyorwa 123, MDR yakatanga kushanda zviri pamutemo muna Chivabvu 26, 2017 uye yakatsiva zviri pamutemo MDD (93/42/EEC) uye AIMDD (90/385/EEC) musi wa26 Chivabvu 2020.

Nekuda kwekukanganisa kweCCIDID-19, chiziviso chekudzokororwa kweMDR yezuva idzva reEU regulation MDR musi wa23 Kubvumbi 2020 yakazivisa zviri pamutemo kuti kuitwa kweMDR kwakamiswa kusvika Chivabvu 26, 2021.

Kutanga kubva Chivabvu 26, 2021, zvese zvekurapa zvichangobva kutangwa muEuropean Union zvinofanirwa kutevedzera zvinodiwa neMDR.

Mushure mekushandiswa kweMDR, zvichiri kugoneka kunyorera zvitupa zveEC zvinoenderana neMDD neAIMDD panguva yemakore matatu ekuchinja uye kuchengetedza kushanda kwezvitupa.Zvinoenderana neChisungo 120 clause2, setifiketi yeEC yakapihwa neNB panguva yeshanduko icharamba ichishanda, asi haingapfuure makore mashanu kubva pazuva rekutumira uye ichapera muna Chivabvu 27, 2024.

Asi, kufambira mberi kweMDR hakuna kumbove kwakatsetseka sezvaitarisirwa, uye mutemo uripo ndewekuti,

May 26, 2024 asati asvika, mabhizinesi anofanirwa kuendesa chikumbiro cheMDR kumitumbi yavo yakaziviswa, ipapo zvitupa zvavo zveMDD (IIb, IIa, uye I zvishandiso) zvinogona kuwedzerwa kusvika Zvita 31, 2028.