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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:
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Device Classification
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Technical File Preparation
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Selection of Certifying Body
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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 pages for more information.
Device Classification
The first step to the CE Mark process
is to properly classify your device. This classification will determine
whether you need a CE Mark and/or need to comply with MDD or IVDD. 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.
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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 MDD and IVDD
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.
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