TÜV Rheinland supports manufacturers in product verification phase, safety and performance, usability and biocomatibility testing, and product certification, techncial documentation assessment and QMS audit. TÜV Rheinland provides impartial testing and conformity assessment services for active and non-active medical devices, components, and software – covering the full range of MDR compliance needs from a single source.

TÜV Rheinland performs impartial conformity assessments for MDR, IVDR, EN ISO 13485, UK MDR, MDSAP and other international requirements – supporting market access in Europe, the UK, the US, Asia, and beyond. Designated under both the MDR and IVDR, TÜV Rheinland offers manufacturers a single, trusted partner for navigating conformity assessment requirements across both regulatory frameworks.

Coordinated project management and structured certification workflows enable efficient assessment while maintaining full impartiality and regulatory compliance. Starting the conformity assessment process early helps manufacturers address MDR requirements systematically – and avoid delays at the point of market entry.