European Authorized Representative for Medical Device Companies

• What are the duties and oblig­a­tions of an EU Autho­rized Rep­re­sen­ta­tive (EC REP)?
• Is it pos­si­ble for me to appoint a dis­trib­u­tor as my representative?
• What do I have to do if I want to change my EC REP?

Inter­est­ed in find­ing out more about cur­rent CE mark­ing require­ments to sell your med­ical devices in Europe? You need to appoint an EU Autho­rized Rep­re­sen­ta­tive (or EC REP), if your com­pa­ny is not domiciled/located in the EU (“non-dom” sta­tus). This EC REP will act as your deputy on behalf of your com­pa­ny in deal­ings with Euro­pean com­pe­tent author­i­ties. You must retain an EC REP as long as you sell your devices or per­form­ing clin­i­cal stud­ies in Europe.

What is the role of an EU Autho­rized Representative?

Your Euro­pean Autho­rized Rep­re­sen­ta­tive is respon­si­ble for reg­is­ter­ing your com­pa­ny in the EUDAMED data­base and com­mu­ni­ca­tion con­tact between you and the nation­al com­pe­tent author­i­ties (Min­istries of Health).

Your des­ig­nat­ed rep­re­sen­ta­tive will also be respon­si­ble for the following:

• Pro­vid­ing assis­tance with spe­cif­ic device reg­is­tra­tions, where necessary
• Pro­vide prod­uct iden­ti­fi­ca­tion plus addi­tion­al infor­ma­tion on all Euro­pean prod­uct labels
• Copy the cur­rent Tech­ni­cal File or CE Dec­la­ra­tion of Con­for­mi­ty to be avail­able for inspec­tion by a Com­pe­tent Author­i­ty, upon request
• Assist with report­ing Inci­dents, Adverse Events and Field Safe­ty Cor­rec­tive Action (FSCA), in col­lab­o­ra­tion with you and your distributors
• Logis­tics

One may also appoint a dis­trib­u­tor as your Autho­rized Rep­re­sen­ta­tive in Europe. This is how­ev­er not rec­om­mend­ed, as a major­i­ty of dis­trib­u­tors are not pre­pared to com­ply with cer­tain manda­to­ry oblig­a­tions of an EC REP. Select­ing an inde­pen­dent rep­re­sen­ta­tive to focus on reg­u­la­to­ry affairs rather than sales and mar­ket­ing, is preferable.

A Euro­pean Autho­rized Rep­re­sen­ta­tive may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Autho­rized Representative.

Find out more about the advan­tages of hir­ing an inde­pen­dent com­pa­ny to act as your EC REP in Europe.

VISAMED is a high­ly spe­cial­ized con­sult­ing com­pa­ny pro­vid­ing a full range of ser­vices to med­ical devices com­pa­nies world-wide. With an expe­ri­enced and ded­i­cat­ed pro­fes­sion­al team spe­cial­ized in med­ical device reg­u­la­tion, qual­i­ty sys­tems and prod­uct devel­op­ment, VISAMED offers a com­pre­hen­sive range of ser­vices, also act­ing as Euro­pean Autho­rized Rep­re­sen­ta­tive for Med­ical Devices Reg­u­la­tion (MDR) (EU 2017/745) and In Vit­ro Diag­nos­tic Reg­u­la­tion (IVDR) (EU) 2017/746 Euro­pean reg­u­la­to­ry affairs and CE Marking.

• Our expe­ri­enced con­sul­tants will eval­u­ate your Tech­ni­cal File, reg­is­ter your med­ical device or In Vit­ro Diag­nos­tic as nec­es­sary, and answer any ques­tions or con­cerns the com­pe­tent author­i­ties might have.
• You will be pro­vid­ed with secure online access to all of your doc­u­men­ta­tion and reg­u­la­to­ry data, includ­ing tech­ni­cal files, labelling infor­ma­tion and sym­bols, lan­guage require­ments, direc­tives, guide­lines, and more.
• Our exten­sive knowl­edge about Euro­pean reg­u­la­tions and the reg­is­tra­tion of devices will facil­i­tate a smooth and effi­cient reg­is­tra­tion process.
• Fre­quent updates will be pro­vid­ed to all of our Autho­rized Rep­re­sen­ta­tion clients, includ­ing vital reg­u­la­to­ry updates focus­ing on Europe.

Have you heard about the spe­cial pack­ages we offer new Euro­pean rep­re­sen­ta­tion clients? Please get in touch with our Euro­pean Autho­rized Rep­re­sen­ta­tive for more infor­ma­tion for detailed infor­ma­tion about Europe autho­rized rep­re­sen­ta­tive ser­vices and learn about the process, costs and timelines.

Please email us if you are look­ing for a Euro­pean Autho­rized Representative.