The regulation of medical devices is changing from directive-based regulation to regulation based on EU regulations. The new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) replace the Medical Devices Directives MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
- MD Regulation EU/2017/745, became fully applicable on 26 May 2021.
- IVD Regulation EU/2017/746, application begins starting from 26 May 2022.
The transition from the application of directives to the application of is step-wise, and the regulations contain transitional provisions.
The national Medical Devices Act 719/2021 that supplements the EU regulations on medical devices entered into force on 19 July 2021. In this same connection, the former Medical Devices Act 629/2010 was renamed as the Act on Certain Medical Devices Specified in EU Directives 629/2010. This renamed act primarily lays down provisions on the national implementation of the IVD Directive, but also on the manufacture and placement on the market of devices covered by the MD and AIMD Directives, insofar as such devices may be placed on the market and put into service under the transitional provisions of the MD Regulation.
Operator and device register notifications related to medical devices to the authorities - Fimea 2/2021
Clinical investigations conducted with medical devices - Fimea 1/2022
CE-marking of Medical Devices (MD and IVD directive) - Fimea 5/2022 (Not available in English)
Performance evaluation studies on in vitro diagnostic medical devices and their reporting- Fimea 2/2022 (Not available in English)
Conformity Assessment of Medical Device (IVD directive) - Fimea 3/2022 (Not available in English)
Manufacturer's Incident report (IVD) - Fimea 4/2022 (Not available in English)
Manufacturer's Incident report - Valvira 1/2010
Registration of Medical Devices - Valvira 2/2010
Healthcare professionals Incident Report - Valrira 4/2010
Conformity Assessment of Medical Devices - Valvira 1/2011
MD Regulation EU/2017/745
IVD Regulation EU/2017/746
IVD Directive 98/79/EC
Medical Devices Act (719/2021)
Act on Certain Medical Devices Specified in EU Directives 629/2010 (Not available in English)
Relation to other legislation
Medicines Act 395/1987 (finlex.fi)
Radiation Act 859/2018 (finlex.fi)