Be confident of medical device market approval
Design dossiers are extensive technical documents which demonstrate that a manufacturer’s product meets the requirements of the Medical Device Directives. Lengthy design dossier examination periods can seriously hamper a manufacturer’s speed to market. Manufacturers also risk having their design dossiers rejected which may result in costly product redesign and repeated long examination process. Having a reputable Notified Body examine your design dossier means you can be assured that your documentation is fully examined against the necessary regulatory requirements.
With our new expedited and flexible design dossier service, we can help reduce the examination period and potentially accelerate your time to market. While this means a prioritization of the project, it does not guarantee certification, as this is dependent on the quality of the submitted documentation.
Provided that no unexpected difficulties occur, the duration of the evaluation (including certification) is approximately 90 working days including one round of questions and answers. This basic service is available for all projects, upon request, we can also offer individual expedited and flexible services. Individual timelines for the examination will be provided by our project coordinators during the planning phase.
To improve the predictability and efficiency of TÜV SÜD’s examinations, you should submit a completed EC application eight weeks prior to the submission of your design dossier or change notification. The completed application should include all required annexes from www.tuv-sud.com/medicaldevice/forms.
Additional information is also required for:
Certification extensions have to be applied a minimum of six months prior to the expiry of your certificate. The extension application should include a complete and updated design dossier in accordance to the Medical Device Directive. Please submit your complete technical documentation file (preferably in STED-format as a searchable PDF) to your local office, to [email protected], or to the following address below.
TÜV SÜD Product Service GmbH
MHS/NAM-DD Assistant’s Office
TÜV SÜD Product Service is an EU Notified Body and can conduct detailed design dossier reviews and issue design examination certificates in accordance with all EU directives concerning medical devices. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own Clinical Centre of Excellence and foreign affairs department, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres.
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Bosnia and Herzegovina