Legislation
ACT AND REGULATONS (currently not available in English)
MD-regulation EU/2017/745 (in English)
IVD-regulation EU/2017/746 (in English)
IVD Directive 98/79/EY (in English)
Medical Devices Act 719/2021 and Medical Devices Act 629/2010
Administrative regulations
Manufacturer's Incident report - Valvira 1/2010
Registration of Medical Devices - Valvira 2/2010
Clinical Investigations of Medical Devices - Valvira 3/2010
Healthcare professionals Incident Report - Valrira 4/2010
Conformity Assessment of Medical Devices - Valvira 1/2011
CE-marking of Medical Devices - Valvira 2/2011