Fimea may grant a temporary derogation for the placing on the market or putting into service of a medical device even if the conformity assessment procedure for the device has not been carried out in accordance with the legislation currently in force if:
- the device is necessary for the protection of public health or the alleviation or treatment of a serious illness or injury of a patient;
- no other equivalent CE-marked device is available; and
- the applicant demonstrates that the general safety and performance requirements pertaining to the device are met.
The derogation may also be granted in exceptional circumstances if:
- the exemption is necessary for the protection of public health;
- the exemption is necessary for safeguarding sufficient availability of the devices; and
- Fimea has sufficient evidence that the general safety and performance requirements pertaining to the device are met.
The derogation is applied for with a free-form application that must be accompanied by the documents based on which the safety and performance requirements of the device concerned can be assessed.
Fimea may impose conditions for the derogation concerning the safety of the device and its use.
Provisions concerning the granting of a derogation for medical devices are laid down in section 58 of the Medical Devices Act (719/2021). With regard to medical devices used for in vitro diagnostics (IVD), the provisions concerning derogations are laid down in section 55 of the Act on Certain Medical Devices Specified in EU Directives (629/2010).
The application can be submitted by post to Fimea's postal address or electronically at firstname.lastname@example.org.
The processing fees charged for derogation applications are based on the Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency (section 11 of the Annex). The processing fee under said Decree is €1,750.