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Performance evaluation and performance studies of IVD-devices

Performance evaluation and performance studies of IVD-devices

A performance evaluation study means a study in which an in vitro
diagnostic medical device is made available to an external party (e.g., a diagnostic laboratory or other healthcare unit); and

  • the conformity of the device has not been demonstrated (non-CE marked); or
  • the original intended purpose or instructions for use of the CE marked device will be derogated from as planned

for the purpose of collecting information about the characteristics and performance or usability of the device in order to demonstrate conformity.

When a performance evaluation study of an IVD device is commenced in Finland, the sponsor shall file a notification with Fimea of the planned study. A Finnish sponsor is required to file this notification irrespective of the country in which the study will be conducted. More detailed provision on the notification and its content are set out in Fimeas Administrative regulation 2/2022.

The study may be commenced immediately when the notification has been submitted to Fimea. Fimea will contact the submitter where necessary if it considers that there are any shortcomings related to the study design. In the event of any substantial changes to the information declared in the notification during the study, Fimea shall be notified thereof.

Any incidents (adverse events) occurring during the study shall be reported to Fimea in accordance with the same principles as when using CE-marked IVD devices (manufacturer’s incident reports and professional user’s incident reports).

Following the application of the IVD Regulation, the notification procedure will be largely replaced by an authorisation procedure. More detailed information about the application and notification procedures for performance studies under the IVD Regulation will be provided as soon as possible. The requirements of the IVD Regulation (2017/746) for performance evaluation and performance evaluation studies are set out in Chapter VI of the Regulation (Articles 56–76,) and in Annexes XIII and XIV to the Regulation.)

The processing fees pertaining to performance evaluation studies are based on the Decree on fees chargeable by the Finnish Medicines Agency.

Administrative Regulation 2/2022: Performance evaluation studies on in vitro diagnostic medical devices and their reporting (Not available in English)

Form: Notification of an IVD device performance evaluation (pdf) (Not available in English)

A notification of a performance evaluation shall be submitted using Fimea’s Secure Mail Service (https://secmail.fimea.fi/) to cie@fimea.fi (further information about secure mail submissions).

The maximum size of a message with attachments sent using the Secure Mail service is 50MB. If the message size exceeds 50MB, the secure mail service will notify of a transmission failure. In such a case, the material to be sent can be divided into several different messages that are clearly indicated as being interrelated. The maximum size of a message with attachments sent using other mailboxes is 10MB.

The signed form complete with attachments may also be sent by post to
Finnish Medicines Agency (Fimea)
Medical Devices
PO Box 55 
FI-00034 FIMEA, Finland