Man­u­fac­tur­ers who are not based in the EU must have an autho­rised rep­re­sen­ta­tive. The EU has pub­lished its first guid­ance, MDCG 2022-16, a 10-page doc­u­ment, clar­i­fy­ing the role of the autho­rised rep­re­sen­ta­tives, an impor­tant func­tion in the con­text of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). 

The autho­rised rep­re­sen­ta­tives’ min­i­mum tasks are list­ed in arti­cle 11(3) of the MDR and IVDR.

The man­u­fac­tur­er and the autho­rised rep­re­sen­ta­tive must set up their writ­ten man­date which in turn shall reflect the min­i­mum require­ments of the MDR and IVDR, arti­cle 11(3), regard­less of whether the autho­rised rep­re­sen­ta­tive is independent/outside of, or is part of, the same larg­er organ­i­sa­tion as the man­u­fac­tur­er. How­ev­er, the man­date may include addi­tion­al respon­si­bil­i­ties agreed between the two participants.

Fur­ther­more, autho­rised rep­re­sen­ta­tives are oblig­ed to com­ply to reg­is­tra­tion require­ments and to ver­i­fy that the man­u­fac­tur­er has ful­filled its reg­is­tra­tion requirements. 

The autho­rised rep­re­sen­ta­tive is legal­ly respon­si­ble for faulty devices on the same basis as, and joint­ly and sev­er­al­ly with, the manufacturer.

Regard­ing lia­bil­i­ty, if the man­u­fac­tur­er is not estab­lished in a mem­ber state and has not ful­filled the require­ments in arti­cle 10, the autho­rised rep­re­sen­ta­tive is legal­ly respon­si­ble for faulty devices on the same basis as, and joint­ly and sev­er­al­ly with, the man­u­fac­tur­er. This is despite the man­u­fac­tur­er not being able to del­e­gate its oblig­a­tions under the MDR and IVDR. So, it is in the autho­rised rep­re­sen­ta­tive inter­est to con­firm that the man­u­fac­ture has sat­is­fied its oblig­a­tions, includ­ing the require­ment to have mea­sures in posi­tion to have ade­quate finan­cial cov­er­age, such as lia­bil­i­ty cov­er­age, under arti­cle 10(16) of the Regulations. 

Final­ly, the man­date should allow the autho­rised rep­re­sen­ta­tive to end the man­date if the man­u­fac­tur­er acts in oppo­si­tion to its oblig­a­tions under the MDR and IVDR. 

Addi­tion­al top­ics are con­sid­ered in the guid­ance, such as lega­cy devices, a change of the autho­rised rep­re­sen­ta­tive and the Per­son respon­si­ble for Reg­u­la­to­ry Compliance.

Should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch with mdi Europa.

Source: MDCG, Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website