(Pre‑)Application Information for Medical Devices
Request for service registration
The MDR and IVDR Regulations impose 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.
TÜV SÜD is one of the largest organisations globally authorized to provide certification services under the MDR, IVDR, MDSAP, ISO 9001, (EN) ISO 13485, and UKMDR requirements.
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Pre-application for certification process
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.
Share your detailed information for an initial service inquiry in our pre-application form.
Application for certification process
Latest after accepting the quotation, you receive the TÜV SÜD application forms from your client contact. The forms can be completed electronically and saved. They shall provide guidance to complete the relevant data for your application for a conformity assessment procedure or the certification of your comprehensive management system for the design and manufacture of medical devices.
Our General Information on Application informs about the terms and conditions for our services. It includes obligations, rights, and duties under the MDR and IVDR.