EU Importer for Man­u­fac­tur­ers of Med­ical Devices

What is an Importer?

The MDR and IVDR define sev­er­al eco­nom­ic oper­a­tor roles. With­in this eco­nom­ic oper­a­tor con­cept, the importer is assigned a cru­cial role, sim­i­lar to the roles of the man­u­fac­tur­er, Euro­pean autho­rized rep­re­sen­ta­tive and dis­trib­u­tor. Sim­ply put, an importer is a nat­ur­al or legal per­son in the EU that places a device from a third coun­try on the Union market.

What are the Oblig­a­tions of an Importer?

Among oth­ers, the importer is oblig­ed to ver­i­fy that:

1. the device has been CE marked and that the EU dec­la­ra­tion of con­for­mi­ty Of the device has been drawn up; 
2. a man­u­fac­tur­er is iden­ti­fied and that an autho­rized rep­re­sen­ta­tive has been des­ig­nat­ed by the manufacturer; 
3. the device is labelled in accor­dance with the MDR and IVDR and accom­pa­nied by the required instruc­tions for use; 
4. a UDI has been assigned by the manufacturer.

How do I Man­date an Importer?

The role of the importer can­not be for­mal­ly man­dat­ed. It is a sta­tus that is acquired auto­mat­i­cal­ly as soon as a nat­ur­al or legal per­son under­takes activ­i­ties that fall with­in the def­i­n­i­tion of an importer, whether vol­un­tar­i­ly or invol­un­tar­i­ly. Often, par­ties are not aware of their oblig­a­tions even though they have already become importers. Don’t risk an inter­rup­tion of your sup­ply chain—partner with us to safe­guard reg­u­la­to­ry com­pli­ance with the applic­a­ble leg­is­la­tion and obligations.

Why Work with mdi Europa?

Coop­er­at­ing with mdi Europa as your importer brings sig­nif­i­cant advan­tages. You will:

1. safe­guard reg­u­la­to­ry com­pli­ance with the applic­a­ble leg­is­la­tion and oblig­a­tions and reduce the risk of sup­ply chain disruption;
2. lessen the bur­den or risk for part­ner dis­trib­u­tors who are poten­tial­ly reluc­tant to take the importer role or who are not aware of the cor­re­spond­ing obligations;
3. facil­i­tate label­ing prac­tice – only one importer name and address needs to be put on your labels; 
4. raise the effi­cien­cy and stream­line process­es need­ed to ful­fill reg­u­la­to­ry requirements.

mdi Europa may also act as your Euro­pean autho­rized representative

In this role, mdi Europa is already very well famil­iar with your prod­ucts. Act­ing also as an importer, mdi Europa will estab­lish a vital link between man­u­fac­tur­er and dis­trib­u­tors. Find out more about this subject:

• Euro­pean Autho­rized Rep­re­sen­ta­tion for Man­u­fac­tur­ers of Med­ical Devices
• EU Autho­rized Rep­re­sen­ta­tive Responsibilities
• EU Autho­rized Rep­re­sen­ta­tive vs. Distributor
• FAQ Sec­tion “Why choose mdi Europa?