How to change your EU Autho­rized Representative

Don’t wor­ry about chang­ing your EU Autho­rized Rep­re­sen­ta­tive! The process became much more for­mal, but not com­pli­cat­ed. We guide you through. 

Change process under the MDR / IVDR

Under the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR), the process of chang­ing your EU Autho­rized Rep­re­sen­ta­tive becomes much more formal. 

Arti­cle 12 of the MDR and IVDR sug­gest an agree­ment between the man­u­fac­tur­er, the out­go­ing Autho­rized Rep­re­sen­ta­tive and the incom­ing Autho­rized Representative.

The agree­ment should at least cov­er the aspects below.

• Date of termination/ begin­ning of the outgoing/ incom­ing Autho­rized Representative’s mandates,
• Date until which the out­go­ing Autho­rized Rep­re­sen­ta­tive will appear on the labeling,
• Trans­fer of documents,
• Oblig­a­tion of the out­go­ing Autho­rized Rep­re­sen­ta­tive to inform the man­u­fac­tur­er or incom­ing Autho­rized Rep­re­sen­ta­tive about any sus­pect­ed inci­dents relat­ed to prod­ucts the out­go­ing Autho­rized Rep­re­sen­ta­tive has been man­dat­ed before.

Do you have any doubts or ques­tions relat­ed to these pro­vi­sions? Please don’t hes­i­tate to get in touch with us!