Bekeng ena re entse lithupelo mabapi le melaoana ea MDR.Hitec Medical e etsa kopo ea setifikeiti sa MDR CE mme e hakanya ho se fumana Mots'eanong o tlang.

Re ithutile ka ts'ebetso ea ntlafatso ea melaoana ea MDR.

Ka May 5, 2017, Official Journal of the European Union e ile ea lokolla ka molao EU Medical Device Regulation (MDR) 2017/745.

Sepheo sa molao ona ke ho netefatsa tšireletso e betere ea bophelo bo botle ba sechaba le polokeho ea bakuli.MDR e tla nkela sebaka sa Directives 90/385/EEC (Active Implantable Medical Device Directive) le 93/42/EEC (Medical Device Directive).Ho latela litlhoko tsa Athikele ea 123 ea MDR, MDR e qalile ho sebetsa ka molao ka la 26 Motšeanong 2017 'me ea nkela MDD (93/42/EEC) le AIMDD (90/385/EEC) ka la 26 Motšeanong 2020.

Ka lebaka la tšusumetso ea COVID-19, tsebiso mabapi le tokiso ea letsatsi la MDR ea MDR e ncha ea taolo ea EU ka la 23 Mmesa, 2020 e phatlalalitse ka molao hore ts'ebetsong ea MDR e chechisetsoe morao ho la 26 Motšeanong 2021.

Ho qala ka la 26 Motšeanong, 2021, lisebelisoa tsohle tsa bongaka tse sa tsoa hlahisoa European Union li tlameha ho latela litlhoko tsa MDR.

Kamora ho kengoa ts'ebetsong ha MDR, ho ntse ho khonahala ho etsa kopo ea litifikeiti tsa CE ho latela MDD le AIMDD nakong ea phetoho ea lilemo tse tharo le ho boloka bonnete ba litifikeiti.Ho latela Article 120 clause2, setifikeiti sa CE se fanoeng ke NB nakong ea phetoho se tla lula se sebetsa, empa se ke ke sa feta lilemo tse 5 ho tloha ka letsatsi la eona la ho fana mme se tla felloa ke nako ka la 27 Motšeanong 2024.

Empa, tsoelopele ea MDR ha e ea ka ea tsamaea hantle joalo ka ha ho ne ho lebelletsoe, 'me leano la hajoale ke le latelang,

Pele ho la 26 Motšeanong 2024, likhoebo li tlameha ho kenya kopo ea MDR ho mekhatlo ea bona e tsebisitsoeng, ebe litifikeiti tsa bona tsa MDD (IIb, IIa, le I lisebelisoa) li ka eketsoa ho fihlela ka la 31 Tšitoe 2028.