Status Quo in Clinical Investigations of Medical Devices: Experience with Requirements, Implementation and Opportunities

The requirements for clinical investigations of medical devices have significantly tightened with the MDR and MPDG. The article describes from a practical perspective the central challenges in planning, conducting, and documenting such studies. Lack of resources, complex submission processes, federal data protection differences, and high qualification requirements characterize the daily reality of many manufacturers and investigation sites. At the same time, new opportunities are emerging through digital processes and decentralized study approaches. The experience demonstrates: Clinical investigations are today both a regulatory obligation and a strategic success factor in the MedTech sector.

Read the full article in the Medizinprodukte Journal (Volume 32, Issue 6, 2025) or via DOI 10.52778/MPJ-2025-0038