Questionnaires and Application Forms for Medical Devices

THE APPLICATIOn FOR certification process

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

Forms

EN ISO 13485, IVDD (new conformity assessments not possible under MDD/AIMDD)

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 guiding checklists, helping you through the complex process of application for, say, a conformity assessment procedure in accordance with Directive.

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 appendices here.

EN ISO 13485 Application certification

Annexes B, C – For medical devices

Annexes B, C – For in vitro diagnostic medical devices

You can find appendices D, F and G at the end of this page.
93/42/EEC (MDD)

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.

If you are looking at how to report a change under an existing MDD certification please find the following appendices.

Application for change notification of QMS/Product under existing MDD certificate in combination with MDR, Art. 120(3)

Appendix A, B, C - Details of product groups and categories, sites and critical suppliers

You can find appendixes D, F and G at the end of this page.
90/385/EEC (AIMDD)

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.

If you are looking at how to report a change under an existing AIMDD certification, please find the following appendices.

Application for change notification of QMS/Product under existing AIMDD certificate in combination with MDR, Art. 120(3)

Appendix A, B, C - Details of product groups and categories, sites and critical suppliers

You can find appendixes D, F and G at the end of this page.
98/79/EC (IVDD)

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.

If you are looking at how to report a change under an existing IVDD certification, please refer to the following appendices.

Application for change notification of QMS/Product under existing IVDD certificate in combination with IVDR, Art. 110(3)

IVDD Appendix A, B, C - Details of product groups and categories, facilities and critical suppliers

You can find appendixes D, F and 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 D - Plans for substantial change(s) to the QMS / product

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.