I-Haiyan Kantyuan yezonyango Isixhobo CO. I-Catheter ye-Caheter ye-Catheter yokusetyenziswa enye, i-oxygen ye-oxygen ye-oxyulas ye-oxyulays yokusetyenziswa enye, i-guessias yomoya, i-anesthesia ye-anesthes ye-Aines yeSheet yokusetyenziswa enye, ukuphefumla ngokusetyenziswa okungatshatanga.

Kuxelwe ukuba i-EU ye-EU ye-EU ye-EU ye-EU ye-EU ngo-MDR (EU 2017/745) yaqala ukusebenza nge-MDE ye-MDD (i-93/42 / i-EEC) ye-GARD SIMED (90/385 / I-EEC), ejolise ekumiseleni inkqubo yolawulo enamhlanje kwaye iqinile ukuze ikhusele impilo nokhuseleko kuluntu nabaguli. Phakathi kwazo, i-MDR ibeka phambili iimfuno ezixineneyo zolovelisi bezinto zonyango malunga nolawulo lomngcipheko kwimveliso, ukusebenza kwemveliso kunye nemigangatho yokhuseleko, uvavanyo lweklinikhi, kunye nokubekwa esweni. Xa kuthelekiswa nomyalelo we-MDD, i-MDRry MDR ibeka esweni eyoyikisayo, i-ceriting enzima ngakumbi, kwaye ihlawula ingqalelo engakumbi kukhuseleko kunye nokusebenza kwemveliso.

I-Kangoan Loonyango ifumene ngempumelelo isiqinisekiso se-MDR ngeli xesha, esingqina ngokupheleleyo ukuba iimveliso ze-Kangyu kunye nezamazwe aphesheya malunga nolawulo lwemveliso, ulawulo lomgangatho kunye nolawulo lomngcipheko kunye nolawulo lomngcipheko kunye nolawulo lomngcipheko.

I-kangoan yezonyango, ethathe inxaxheba ngokunzulu kwimarike yaseYurophu ngaphezulu kweminyaka elishumi, ukufunyanwa kwesiqinisekiso se-MDR liyinto ebalulekileyo. , I-Latin America kunye nezinye iimarike zinike inkxaso eqinileyo.