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?
* 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
Arab Health Assessment Routes BfArM Brexit Case Study ce-marking-service CE Marking Certificates of Free Sale Certificates Service Checklists Clinical Evaluation COVID-19 Drug Device Combination EU Authorized Representative EU Authorized Representative Service EUDAMED European Authorised Representative European Commission FAQ FAQ Section Service Guidance Documents Inside Informations IVDD IVDR IVDR News Legacy Devices MDCG MDD MDR mdr-service MDR News Medical Devices Network-Service News in Brief No-Deal Brexit Notified Body OEM Performance Evaluation PPE Regulatory Affairs Security Advice Templates UDI Unique Device Identification WHO