Acts supplementing EU regulations on medical devices now approved
The President of the Republic has approved the Acts supplementing the EU regulations on medical devices. The Acts will enter into force on 19 July 2021.
The Acts that are now about to enter into force are the new Medical Devices Act and the Act amending the current Medical Devices Act. 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.
The new Medical Devices Act lays down provisions on the matters in respect of which the EU regulations require or enable the issuance of national provisions. For example, the Act lays down provisions on the powers of public authorities, the language requirements for documents, the obligations concerning healthcare, the annual fee charged from operators and the sanctions for breaches of legislation. The Act also contains provisions on clinical investigations and studies concerning the performance of medical devices.
The Act concerning in vitro diagnostic medical devices, i.e. medical devices used for the external examination of samples taken from the human body, will not be applied in full until 2022. Until then, Finland will apply the Directive on in vitro diagnostic medical devices and also the Directives on medical devices that preceded the relevant EU regulations, but only in certain cases in accordance with the transitional provisions of the EU regulations. For this reason, the current Medical Devices Act, which has implemented the said Directives, will remain partly in force. However, the Act has been amended in many respects and its name has changed. The new name is the Act on Certain Medical Devices Specified in EU Directives.
Inquiries
Mari Laurén-Häussler, Senior Specialist, Legal Affairs, tel. +358 295 163 762, [email protected]