Gap analysis and early preparation is key towards successful certification according to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements.
As one of the leading EU Notified Body for all types of medical devices and in-vitro diagnostics covered by EU directives and regulations, TÜV SÜD Product Service is prepared and working closely with the Authorities to get designation as a Notified Body under the new MDR and IVDR.
TÜV SÜD offers the following services to help you prepare:
- General MDR and IVDR Training (Public and In-House)
- Modular TD Assessments following the official application for certification
- MDR and IVDR Workshops