Regulatory Affairs

US tariffs on medical devices: What manufacturers need to consider now On April 9, 2025, the US government surprisingly announced a 90-day pause in tariffs. [...]

Regulatory overlaps in medical technology: MDR/IVDR, AI Act and data protection in focus The integration of artificial intelligence (AI) in medical devices

Regulatory resilience as a success factor for the global market access of medical devices In an increasingly complex regulatory landscape, manufacturers of medical devices are faced with a number of challenges.

QMSR replaces QSR: What medical device manufacturers need to know now From February 2, 2026, a new regulatory framework will apply in the USA.

Medtech market 2025: trends, challenges and how manufacturers can remain successful The medical technology industry in Germany is facing a challenging year in 2025.

MDR Ready - What importers and distributors need to consider now Regulation (EU) 2017/745 (Medical Device Regulation, MDR) has been in force since

National requirements for the approval of medical devices in Spain Spain is one of the largest markets for medical technology in Europe and

National requirements for the approval of medical devices in France France is one of the most important markets for medical technology in Europe. The

National requirements for the approval of medical devices in Germany Germany is one of the largest medical technology markets in the world and, as an EU member state, is subject to

Approval of medical devices in Italy - A guide for manufacturers The approval of medical devices in Italy is based on the European