Application Forms Questionnaires & Application Forms

The relevant steps on how a TÜV SÜD application for certification of a Medical Device and IVD takes place is summarised in Service Description MDR and Service Description IVDR.

Regulation 2017/745 (MDR) 

The MDR imposes strict demands on medical device manufacturers and the notified bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.

With more than 750 medical device professionals in more than 30 locations worldwide, TÜV SÜD is one of the largest organisations globally authorized to provide certification services under the EU’s MDR.

Request for MDR Service Registration

*Please note that the submission of this form is not a pre-application or application for MDR services. 

 MDR – General Information on Application

REGULATION 2017/746 (IVDR)

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.

As one of the world’s largest EU Notified Body for all types of medical devices covered by EU regulations, TÜV SÜD Product Service GmbH is designated as a Notified Body under the IVDR.

Request for IVDR Service Registration

*Please note that the submission of this form is not a pre-application or application for IVDR services.

IVDR – General Information on Application

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.