The require­ments for med­ical device man­u­fac­tur­ers in the EU have increased con­sid­er­ably in recent years due to the intro­duc­tion of the Med­ical Devices Reg­u­la­tion (MDR) and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). One of the key changes is the EUDAMED data­base, a com­pre­hen­sive infor­ma­tion sys­tem that mon­i­tors among oth­ers the reg­is­tra­tion and vig­i­lance of med­ical devices. Using the EUDAMED data­base requires detailed exper­tise and pre­cise com­pli­ance with reg­u­la­to­ry require­ments – this is where mdi Europa comes in.

mdi Europa: Your part­ner for vig­i­lance and EUDAMED registrations

That’s why we offer com­pre­hen­sive ser­vices to help you ful­fill these com­plex require­ments with­out tying up valu­able resources in your company. 

As an expe­ri­enced com­pa­ny in reg­u­la­to­ry affairs for med­ical devices, mdi Europa offers cus­tomized solu­tions for med­ical device man­u­fac­tur­ers. Our aim is to pro­vide you with opti­mal sup­port in all aspects of vig­i­lance and the reg­is­tra­tion of your prod­ucts in the EUDAMED data­base. We under­stand that com­pli­ance with the MDR and IVDR is a chal­lenge – espe­cial­ly for small and medi­um-sized com­pa­nies. That’s why we offer com­pre­hen­sive ser­vices to help you ful­fill these com­plex require­ments with­out tying up valu­able resources in your company. 

Our ser­vices at a glance

EUDAMED reg­is­tra­tion: mdi Europa takes care of the com­plete reg­is­tra­tion of your med­ical devices and com­pa­nies in the EUDAMED data­base for you. We ensure that all data is entered cor­rect­ly and on time so that you can con­cen­trate on your core business.

Vig­i­lance: Our team is on hand to help you mon­i­tor and report inci­dents. Thanks to our many years of expe­ri­ence in the field of post-mar­ket sur­veil­lance, we sup­port you in rec­og­niz­ing and report­ing poten­tial inci­dents at an ear­ly stage – always in accor­dance with legal requirements.

Why mdi Europa?

Expe­ri­ence: mdi Europa has exten­sive exper­tise in work­ing with med­ical device man­u­fac­tur­ers and in the imple­men­ta­tion of Euro­pean regulations.

Cus­tomized sup­port: We tai­lor our ser­vices to the exact needs of your com­pa­ny, regard­less of size or prod­uct category.

Reli­a­bil­i­ty: Our experts ensure time­ly and pre­cise imple­men­ta­tion of all reg­u­la­to­ry require­ments so that you are always on the safe side.

The EUDAMED data­base and vig­i­lance oblig­a­tions need not be a chal­lenge. With mdi Europa at your side, you can mas­ter these require­ments while ensur­ing the com­pli­ance of your products.

Con­tact us today to find out how we can help you reli­ably ful­fil the require­ments of the EUDAMED data­base and vig­i­lance. Togeth­er, we will ensure that your prod­ucts remain safe and com­pli­ant on the Euro­pean market.

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website