For Customers and Suppliers
For Customers and Suppliers
Note: TÜV SÜD America Standard Terms & Conditions and TÜV SÜD America Standard Terms & Conditions have been updated as of 11/05/2022 to reflect updated address information.
Terms & Conditions:
Note: Updated as of October 29, 2021
EMCU_F09.02E [ DOC 456 kB ] Test Plan / Constructional Data Form
EMCU_F0904E [ DOC 84 kB ] Block Diagram
On Site Testing
UEMC0919 [ DOC 34 kB ] Test Plan - On Site Testing
ISO 13766 / ISO 14982
UEMC0920 [ DOC 80 kB ] Test Plan - Agriculture & Forestry Machinery
FDA Reviewers Guide
UEMC0921 [ DOC 174 kB ] Test Plan - FDA Reviewers Guide
EN 61326:1997 + A1 1998 + A2: 2001 + A3: 2003
UEMC0925 [ DOC 38 kB ] Clause 7 - Emissions Test Plan Details
EN 61326:1997 + A1 1998 + A2: 2001 + A3: 2003
UEMC0929 [ DOC 92 kB ] Clause 7 - Immunity Test Plan Details
For questions regarding medical forms on this site, please contact us. The new TÜV SÜD digital 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.
EN ISO 13485
EN ISO 13485 Application certification [ PDF 461 kB ]
93/42/EEC MDD
MDD Application [ PDF 694 kB ] for performance/change/extension of a conformity assessment procedure
MDD Appendix A [ PDF 418 kB ] Details on product groups and categories
98/79/EC IVDD
IVDD Application [ PDF 571 kB ] for performance/change/extension of a conformity assessment procedure
IVDD Appendix A [ PDF 106 kB ] Details on product groups and categories
90/385/EEC AIMD
AIMD Application [ PDF 659 kB ] for performance/change/extension of a conformity assessment procedure
AIMD Appendix A [ PDF 140 kB ] Application for performance of a conformity assessment procedure in accordance with 90/385/EEC
Additional Appendices for the Application Forms
Appendix B [ PDF 404 kB ] Details on sites covered by the same QMS
Appendix C [ PDF 404 kB ] Details on critical suppliers not covered by the same QMS
Appendix D [ PDF 577 kB ] Plans for substantial change(s) to the QMS/product
Appendix E [ PDF 673 kB ] Extension of EC certificates
Appendix F [ PDF 383 kB ] Space for additional information
Appendix G [ PDF 385 kB ] Change of Certification Body/Notified Body
Guidance for Preparation of Documentation File(s) [ DOC 108 kB ]
UMDNS Codes [ DOC 1994 kB ]
Product Safety Testing
Change Notification for Product Safety Testing according to CB, NRTL, and TUV SUD Mark scheme and for testing without certification [ PDF 247 kB ]
Field Incident Report [ DOC 47 kB ]
Application for an Upgrade Audit to AS9100D or AS9120B [ DOCX 31 kB ]
Site Selector
Global
Americas
Asia
Europe
Middle East and Africa
