Medical devices illustration

Legislation

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

Finnish Medicines Agency Administrative Regulation - Operator and device register notifications related to medical devices to the authorities (Fimea 2/2021) (in English)

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