English translation of the national Medical Devices Act 719/2021 now published in Finlex
The Acts supplementing the EU regulations on medical devices entered into force on 19 July 2021. The English translation of the national Act 719/2021 published on that occasion has now been published in Finlex. Only the Finnish and Swedish versions are legally binding, but an English translation is now also available as reference for operators.
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 national 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 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 to the current regulation. As a completely new matter, the Act defines supervision fees for operators, which will be introduced in stages.
In addition to these, the Act also contains provisions on the competences of authorities, the language requirements for documents, the obligations concerning health care and the sanctions for breaches of legislation, as well as provisions concerning clinical device investigations.
The registrations and notification obligations related to medical devices are summarised under section 49 and in Fimea Administrative Regulation 2/2021.
News article 27 July 2021: Laws supplementing EU regulations on medical devices come into force
Operator and device register notifications related to medical devices to the authorities: Administrative Regulation 2/2021 (Finlex, in Finnish)
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
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