CE Mark / MDD / IVDD / AIMDD

CE Mark / MDD / IVDD / AIMDD

CE Mark is the European Community requirement for selling devices within Europe. This means that without the CE Mark you cannot sell your medical device within the European Community. The CE Mark represents compliance with a specific device directive which can be achieved through self assessment or a certification body depending upon the device classification. For medical devices, the European Community requires compliance with the three special directives (Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD) and the Active Implantable Medical Device Directive (AIMDD)) in order to put the CE Mark on your device.

mdi Consultants can guide you to determine what is the best way to achieve a CE Mark and assist you through the entire process of securing it. We have helped over 100 companies successfully achieve the CE Mark. Our customer testimonials will provide you a glimpse of the experience of working with mdi on CE Marking.

Our CE Mark services include:
Device Classification
The first step to the CE Mark process is to properly classify your device. This Device Classification will determine whether you need a CE Mark and/or need to comply with MDR or IVDR. In addition, as part of this classification, we will determine whether you can self-certify your device or if you need to contact a certifying body

Technical File Preparation
As part of the CE requirements a Technical File (TF) has to be prepared to outline the safety requirements of the product. The TF will be created in line with MDR and IVDR requirements. mdi will assist you in the preparation of the Technical File to meet the review of the third party certification.

Selection of Certifying Body
The CE Mark Certification may require a third party review of the Technical File to assure conformity to the standard. mdi will assist you in the selection of this Certifying Body, prepare the application and be present during the certification audit.

”Responsible Person” Assistance
As part of the CE mark requirements, a “Responsible Person” in Europe is required to be indicated in your Technical File and on your product’s labeling. mdi has representatives in Europe that work as an European Addressee to act as this “Responsible Person”, who will maintain your Letter of Conformity, review complaints, report events, act as your Notified Body Liaison and maintain your Technical Files.

In addition, the successful application of a CE Mark may require compliance with the ISO set of global quality standards. mdi can also help you to achieve ISO certification.