Numer­ous man­u­fac­tur­ers have appoint­ed a dis­trib­u­tor as their EU Autho­rized Rep­re­sen­ta­tive. This may cause severe prob­lems for sev­er­al rea­sons. Find out, what you have to con­sid­er and how you can avoid tak­ing steps you might regret deeply.

Why should man­u­fac­tur­ers not appoint their dis­trib­u­tor as EU Autho­rized Representative? 

Under the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR), the EU Autho­rized Rep­re­sen­ta­tive is assigned a piv­otal role. Dis­trib­u­tors may have dif­fi­cul­ties ful­fill­ing the cor­re­spond­ing requirements. 

Read about five impor­tant points that should be con­sid­ered when choos­ing your EU Autho­rized Representative

  1. Reg­u­la­to­ry Compliance
  2. Tech­ni­cal File
  3. Inci­dent Report­ing & Gen­er­al Surveillance
  4. Inde­pen­dence & Neu­tral­i­ty of your Autho­rized Representative
  5. Gen­er­al Issues with appoint­ing your Distributor

1. Reg­u­la­to­ry Compliance

An EU Autho­rized Rep­re­sen­ta­tive will be respon­si­ble for ver­i­fy­ing that the Dec­la­ra­tion of Con­for­mi­ty and Tech­ni­cal Doc­u­men­ta­tion have been drawn up and that the applic­a­ble con­for­mi­ty assess­ment pro­ce­dure has been car­ried out. Your Autho­rized Rep­re­sen­ta­tive should have detailed knowl­edge of all the indi­vid­ual Reg­u­la­tions of each of the EU mem­ber states.

2. Tech­ni­cal File

Your EU Autho­rized Rep­re­sen­ta­tive will have to retain a copy of your Dec­la­ra­tion of Con­for­mi­ty, Tech­ni­cal File and rel­e­vant cer­tifi­cates and must allow the com­pe­tent author­i­ties of all EU mem­ber states access to that infor­ma­tion and data.

3. Inci­dent Report­ing & Gen­er­al Surveillance

Your EU Autho­rized Rep­re­sen­ta­tive will be aware of inci­dents in all EU mem­ber states. He will han­dle sen­si­tive prod­uct infor­ma­tion, like Euro­pean mar­ket infor­ma­tion, dis­trib­u­tor lists etc. An Autho­rized Rep­re­sen­ta­tive may be required to make deci­sions that are con­trary to a distributor’s inter­ests, such as prod­uct recalls. As such, the Autho­rized Rep­re­sen­ta­tive must be able to decide inde­pen­dent­ly and to your best reg­u­la­to­ry inter­ests at all times.

Appoint­ing a dis­trib­u­tor as Autho­rized Rep­re­sen­ta­tive can cause a seri­ous con­flict of inter­est for you in the Euro­pean market. 

4. Inde­pen­dence & Neu­tral­i­ty of your Autho­rized Representative

An EU Autho­rized Rep­re­sen­ta­tive must remain neu­tral in all actions, includ­ing being neu­tral towards pos­si­ble com­pet­i­tive distributors.

5. Gen­er­al issues with appoint­ing your distributor

One should be aware of the inher­ent risk in appoint­ing one of your Euro­pean dis­trib­u­tors. This prac­tice will inevitably lead to a hier­ar­chi­cal sit­u­a­tion amongst your dis­trib­u­tors, those not appoint­ed as Autho­rized Rep­re­sen­ta­tive would per­ceive them­selves as less sig­nif­i­cant, espe­cial­ly as only the Autho­rized Representative’s name appears on the labeling.

Chose your EU Autho­rized Rep­re­sen­ta­tive care­ful­ly before enter­ing the EU Mar­ket, to avoid increas­ing costs and stress.

As it is a legal require­ment to include your Autho­rized Representative’s details on your labels and pack­ag­ing, chang­ing your Autho­rized Rep­re­sen­ta­tive is expen­sive, inef­fi­cient and cum­ber­some. It involves the reprint­ing of labels and pack­ag­ing with the new Autho­rized Representative’s details, as well as scrap­ping of all print­ed stock on hand. It is strate­gi­cal­ly pru­dent to appoint an inde­pen­dent rep­re­sen­ta­tive at the out­set thus avoid­ing unnec­es­sary com­pli­ca­tions, expense and dis­con­tent­ment later.

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