Full-Ser­vice EU Mar­ket Entry for Med­ical Device Manufacturers

EU Autho­rized Representative

mdi Europa GmbH acts as Euro­pean Autho­rized Rep­re­sen­ta­tive, as defined in the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR).

CE Mark­ing Specialists

Our high­ly qual­i­fied reg­u­la­to­ry affairs spe­cial­ists pro­vide hands-on expe­ri­ence and have reg­is­tered hun­dreds of med­ical device man­u­fac­tur­ers for CE Mark­ing with the Euro­pean com­pe­tent authorities.

EU Importer

Have you ver­i­fied that your med­ical devices are import­ed in accor­dance with the applic­a­ble reg­u­la­to­ry require­ments? Coop­er­ate with mdi Europa as your EU importer to pre­vent non-con­for­mi­ties in your dis­tri­b­u­tion chain.

Swiss Autho­rized Representative

Do you want to place your med­ical devices on the mar­ket in Switzer­land? If you don’t have your own loca­tion with­in the region, you need a local rep­re­sen­ta­tive, a so-called Swiss Autho­rized Rep­re­sen­ta­tive. mdi Europa can help you to ful­fill the cor­re­spond­ing requirements.

UK Respon­si­ble Person

Do you want to place your med­ical devices on the mar­ket in Great Britain? If you don’t have your own loca­tion with­in the region, you need a local rep­re­sen­ta­tive, a so-called UK Respon­si­ble Per­son (UKRP). mdi Europa can help you to ful­fill the cor­re­spond­ing requirements.