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mdi Consultants' CE Mark Services

CE Mark Services for MDR, IVDR, and AIMDD

CE mark

A CE Mark is the European Community requirement for selling medical devices within Europe. Without a  CE Mark, you cannot sell your medical device product within the European Community. The CE Mark represents compliance with a specific EU Medical device directive, which is achieved through self-assessment or via an EU certification body, depending upon the device’s classification. To put the CE Mark on your medical devices, the European Community requires compliance with the three special directives: the Medical Device Regulation (MDR); the In-Vitro Diagnostic Regulation (IVDR); and, the Active Implantable Medical Device Directive (AIMDD).

mdi Consultants’ CE Mark Service can guide you to determine the best way to achieve a CE Mark, and assist you through the entire process of securing it. We have consulted and worked with over 100 companies to successfully achieve the CE Mark. Our clients’ testimonials will provide you a glimpse of the experience of working with mdi on CE Marking.

mdi Consultants CE Mark services include:

  • Device Classification
  • Technical File Preparation
  • Selection of Certifying Body
  • Responsible Person Assistance

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. Visit our ISO Compliance page for more information.

ISO certification

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CE Mark Services

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.