I kēia pule ua alakaʻi mākou i ka hoʻomaʻamaʻa ʻana i nā lula MDR.Ke noi nei ʻo Hitec Medical no ka palapala MDR CE a manaʻo e loaʻa iā Mei aʻe.

Ua aʻo mākou e pili ana i ke kaʻina hana o nā hoʻoponopono MDR.

Ma ka lā 5 o Mei, 2017, ua hoʻokuʻu ʻia ka Official Journal of the European Union i ka EU Medical Device Regulation (MDR) 2017/745.

ʻO ke kumu o kēia hoʻoponopono e hōʻoia i ka palekana maikaʻi o ke olakino lehulehu a me ka palekana maʻi.E pani ana ʻo MDR i nā Directives 90/385/EEC (Active Implantable Medical Device Directive) a me 93/42/EEC (Medical Device Directive).Wahi a nā koi o MDR Paukū 123, ua hoʻomaka ʻia ka MDR ma Mei 26, 2017 a ua hoʻololi hou ʻia ʻo MDD (93/42/EEC) a me AIMDD (90/385/EEC) ma Mei 26, 2020.

Ma muli o ka hopena o ka COVID-19, ua hoʻolaha ʻia ka leka hoʻomaopopo i ka hoʻoponopono ʻana i ka lā MDR o ka hoʻoponopono EU hou MDR ma ʻApelila 23, 2020 ua hoʻopanee ʻia ka hoʻokō ʻana o ka MDR i Mei 26, 2021.

E hoʻomaka ana mai Mei 26, 2021, pono nā lāʻau lapaʻau āpau i hoʻokuʻu ʻia i ka European Union e hoʻokō i nā koi MDR.

Ma hope o ka hoʻokō ʻana o MDR, hiki nō ke noi no nā palapala CE e like me MDD a me AIMDD i ka wā hoʻololi ʻekolu makahiki a mālama i ka mana o nā palapala hōʻoia.Wahi a ka Paukū 120 clause2, ʻo ka palapala CE i hoʻopuka ʻia e NB i ka wā o ka hoʻololi ʻana e hoʻomau ʻia, akā ʻaʻole ʻoi aku ma mua o 5 mau makahiki mai kona lā hoʻopuka a e pau i ka Mei 27, 2024.

Akā, ʻaʻole i maʻalahi ka holomua o ka MDR e like me ka mea i manaʻo ʻia, a penei ke kulekele o kēia manawa.

Ma mua o Mei 26, 2024, pono nā ʻoihana e waiho i kahi noi no MDR i ko lākou mau kino i hoʻomaopopo ʻia, a laila hiki ke hoʻonui ʻia kā lākou palapala MDD (IIb, IIa, a me I) a hiki i Dekemaba 31, 2028.