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Questionnaires and Application Forms for Medical Devices

Ensure quality at the heart of your operations

The certification process

The relevant steps on how a TÜV SÜD certification of a Medical Device takes place is summarised here.

Forms

Request for Quotation Questionnaire
EN ISO 13485, AIMDD, MDD, IVDD, Tissue of Animal Origin

Application Forms for Medical Devices

The new TÜV SÜD digital application forms can be completed electronically and saved. They can be used not only as applications but also as guidelines and checklists, helping you through the complex process of application for, say, a conformity assessment procedure in accordance with Directive 93/42/EEC (MDD).

In addition, help texts are provided for sections of the form that need explanation, facilitating completion of the forms and supplying valuable supplementary information that reduces the need for queries and research. They include references to the official websites of the competent commission/authority and further documents. You can thus inform yourself in a targeted manner about individual aspects without further research efforts.

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  • EN ISO 13485

    If you are looking for a certification of your comprehensive management system for the design and manufacture of medical devices, please use this application and these appendixes here.

    You can find appendixes B to G at the end of this page.

  • 93/42/EEC (MDD)

    If you are looking for a certification of a product which is a medical device in terms of the following definition, please use this application and these appendixes here.

    Medical device means: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the following purposes:

    You can find appendixes B to G at the end of this page.

  • 90/385/EEC (AIMD)

    If you are looking for a certification of a product which is an active implantable medical device in terms of the following definition, please use this application and these appendixes here.

    Active implantable medical device means: any active medical device which is intended to be totally or partially introduced surgically or medically into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

    You can find appendixes B to G at the end of this page.

  • 98/79/EC (IVDD)

    If you are looking for a certification of a product which is an in vitro diagnostic medical device in terms of the following definition, please use this application and these appendixes here.

    According to the Directive, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, and systems that are intended for use in the examination of specimens taken from the human body (tissue, blood, urine, etc.) to diagnose diseases, to monitor a person’s state of health, or to monitor therapeutic procedures.

    You can find appendixes B to G at the end of this page.

  • CB/ NRTL/ TÜV SÜD Mark

    If you performed product testing with TÜV SÜD according to CB, NRTL, or TÜV SÜD mark scheme or testing without a certification, please use this form to report plans for substantial changes to the product.

    Change notification for product testing according to CB, NRTL, and TÜV SÜD-Mark scheme and for testing without certification

    For additional information please use Appendix F

  • Appendixes for the application forms

    Appendix B - Details on sites covered by the same QMS

    Appendix C - Details on critical suppliers not covered by the same QMS

    Appendix D - Plans for substantial change(s) to the QMS / product

    Appendix E - Extension of EC certificates

    Appendix F - Space for additional information

    Appendix G  - Change of Certification Body/Notified Body Transfer Agreement

    Click here to download the Transfer Agreement as a Word file.

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