Of course, CE Mark­ing is com­pli­cat­ed. If you are a man­u­fac­tur­er, an im- or exporter or a dis­trib­u­tor, your key com­pe­tence prob­a­bly cen­ters more around engi­neer­ing, sales or orga­niz­ing end­less sup­ply chains rather than com­mu­ni­cat­ing with Noti­fied Bod­ies. So why not leave the crazy part of enter­ing the EU mar­ket to the experts?

Grab your tow­el, the work will be done

Our biggest con­cern is to give you all the sup­port and pro­vide all the infor­ma­tion you need and still keep it easy for you. So leave all the reg­u­la­to­ry stress behind, grab your tow­el and enjoy a day at the beach while our team of experts runs the pro­ce­dures of CE Mark­ing for your med­ical devices and in vit­ro diag­nos­tics. If we could, we would even serve you a refresh­ing drink with it. 

What about you?

Since the year 2000 mdi Europa guid­ed hun­dreds of com­pa­nies as their Euro­pean Autho­rized Rep­re­sen­ta­tive* through the EU reg­u­la­to­ry jun­gle. Start-ups as well as estab­lished firms through­out the world have eas­i­ly made their mar­ket appear­ance or gained new mar­ket areas with the help from our team. What about you? Would you join the trip to the beach today?

A lit­tle relax­ing pre­view on your day

How can we make your life eas­i­er today? 

You might pay a vis­it to our FAQ sec­tion,
or vis­it our page “CE Mark­ing” and its sub­or­di­nate top­ics to find out every­thing around CE con­sult­ing – includ­ing hot top­ics like new Reg­u­la­tions MDR and IVDR,
or con­tact our team, if you like to leave a request.

What else would you like to find out?

Use the man­i­fold ways to search our infor­ma­tive web­site, like key­words, cat­e­gories and the full text search option or browse through our exten­sive library sec­tion.

* As defined in the Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR), the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR), the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD), the Med­ical Devices Direc­tive 93/42/EEC (MDD) and the In Vit­ro-Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD).

Use fol­low­ing key­words (tags) for brows­ing mdi-Europa.com

About mdi Europa AIMDD Arti­fi­cial Intelligence Assess­ment Routes BfArM Brex­it Case Study CE Mark­ing Cer­tifi­cates of Free Sale Check­lists Clin­i­cal Evaluation COVID-19 Down­load Section Drug Device Combination EU Autho­rized Representative EUDAMED Euro­pean Commission Fea­tured Content Guid­ance Documents Inside Infor­ma­tions IVDD IVDR Lega­cy Devices Leg­is­la­tion Documents Link Sec­tion MDCG MDD MDR Med­ical Devices News in Brief No-Deal Brex­it Noti­fied Body OEM Per­for­mance Evaluation PPE Reg­u­la­to­ry Affairs Secu­ri­ty Advice Sup­port­ive Information Tem­plates UDI Unique Device Identification Vig­i­lance WHO

Use cat­e­gories to select your top­ic on our website

Or use our full text search func­tion for your enquiries