Derogation
Fimea may grant a temporary derogation for the placing on the market or putting into service of a medical device. Derogations are regulated under Article 59 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 54 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Provisions concerning the granting of a derogation for medical devices are laid down in section 58 of the Medical Devices Act (719/2021). A derogation may be granted provided that the conditions described below are fulfilled. In both cases, all three conditions must be met. In practice, the manufacturer of the devices is the party that can provide the authority with information demonstrating that the device complies with the general safety and performance requirements.
A derogation may be granted 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.
Fimea may impose conditions for the derogation concerning the safety of the device and its use.
Applying for the derogation
The applicants are advised to contact Fimea via email [email protected] already when preparing the application.
The derogation is applied for by using the application form below or with a free-form application which includes detailed information about the device, manufacturer, and information based on which the provisions concerning the granting of derogation are filled. A cover letter, which clearly describes the need for a derogation, should also be included.
The application should be accompanied by the applicable documents listed in the application form.
The application can be submitted by post to Fimea's postal address or electronically via secure mail by using the e-mail address: [email protected].
Time required for processing the applications varies. This is why we advice to reserve enough time for processing the application.
Fees
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. Please see more information via webpage: Fees for Medical Devices.
More information
MD regulation (EU) 2017/745 (EURLex)