AmCham Slovakia

AmCham Slovakia has submitted its position to the European Commission on the targeted revision of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The position calls for a more proportionate, predictable and efficient regulatory framework that maintains high patient-safety standards while supporting innovation and the continued availability of medical devices and diagnostics across the EU.

It also highlights the specific impact of regulatory complexity on smaller markets such as Slovakia, where disproportionate costs and administrative burdens may reduce product availability and limit patients’ access to essential and innovative technologies.

The full AmCham Slovakia position paper is available in the attached PDF document below.