Laws supplementing EU regulations on medical devices come into force

The Acts supplementing the EU regulations on medical devices came into force on 19 July 2021. The Medical Devices Act 719/2021 and the Act on Certain Medical Devices Specified in EU Directives 629/2010 entered into force. In addition, technical amendments have been made to certain other Acts. The aim of the Acts is to improve the safety of patients and medical devices.

Medical Devices Act 719/2021

The Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) became mandatory on 26 May 2021. The new Medical Devices Act (719/2021) lays down provisions on the matters in respect of which the EU regulations require or enable the issuance of national provisions. One of the most important requirements of the new Act is the registration obligation of operators distributing medical devices to professional users and retailers. This obligation will enable distributors to monitor and improve the traceability of medical devices when problems arise. The new Act prohibits the reprocessing of single-use devices, which corresponds with the current regulation. As a completely new issue, the Act defines operators' supervisory fees, which will be introduced in stages. In addition to these, the Act also contains provisions on the powers of authorities, the language requirements for documents, the obligations concerning health care, the sanctions for breaches of legislation and the provisions concerning clinical equipment examinations.

Act on Certain Medical Devices Specified in EU Directives on in vitro diagnostic medical devices (629/2010)

Regulation (EU) 2017/746 (IVDR) on diagnostic medical devices used in external examinations, i.e. in vitro diagnostic devices, will only be fully applied in 2022. Until then Directive 98/79/EC applies on in vitro diagnostic medical devices and in certain situations, on the basis of transitional provisions of EU regulations, the Directives on medical devices that preceded the relevant EU regulations. For this reason, Act 629/2010 on healthcare equipment and consumables remains partially in force. However, Act 629/2010 has been amended to correspond with the implementation of the regulation of medical devices whose regulation is still based on a directive. The name of the Act has also been changed to correspond with its content and the terminology used. The new title is the Act on Certain Medical Devices Specified in EU Directives 629/2010. In addition, certain provisions issued by the National Supervisory Authority for Welfare and Health (Valvira) pursuant to the Act 629/2010 remain in force even after the amendment to the Act, as applicable, to the extent that the amended legislation does not otherwise provide for.

The implementation of the Acts will be supplemented by the provisions of the Finnish Medicines Agency Fimea, which will be published later.

Read more:

Acts supplementing EU regulations on medical devices now approved - Ministry of Social Affairs and Health, press release (stm.fi)

Medical Devices Act 719/2021 - Finlex (in Finnish)

Act on Certain Medical Devices Specified in EU Directives 629/2010 (in Finnish)

Regulation (EU) 2017/745 (MDR): MD Regulation EU/2017/745

Regulation (EU) 2017/746 (IVDR): IVD Regulation EU/2017/746

IVD Directive 98/79/EC