Medical device and IVD studies in Finland
Clinical investigations under the MDR and performance studies under the IVDR: submissions to the ethics committee and Fimea, site start-up and monitoring to ISO 14155, by a team based in Finland.
Device studies follow their own rules
A device study is not a drug trial with a different product. The regulation, the standard, the submission route and even the order of the approvals are different. Our team does this work every month: in 2026 most of our submissions have been for device and IVD studies.
Which study do you have?
The route depends on the device, its CE mark and what the results will be used for.
Device without a CE mark
A clinical investigation for conformity assessment under MDR Article 62. Fimea authorises it on an application. The same route applies to a CE-marked device that is studied outside its intended purpose.
CE-marked device
A post-market clinical follow-up (PMCF) study within the intended purpose. If participants undergo additional invasive or burdensome procedures, Fimea is notified at least 30 days before the start (Article 74(1)). Investigator-initiated studies and early pilots whose results are not used for conformity assessment need an application under Article 82 and Finnish law.
IVD performance study
An application to Fimea is needed when the sample is taken by a surgically invasive procedure only for the study, when the result may influence patient care, or when the study adds invasive procedures or other risks (IVDR Article 58). A companion diagnostic study needs an application; if it uses only left-over samples, a notification at least 10 days before the start is enough.
Combined with a medicinal product trial
The drug part goes through CTIS and the device or IVD part to Fimea, and the national committee Tukija does the ethics review. Finland has no single harmonised process for these yet (an EU pilot, COMBINE, is testing one), so both routes have to be planned together from the start.
What we take care of
Take the whole service or only the parts you need.
Route and timeline
We confirm which article applies to your study and what the ethics committee and Fimea need, and build a timeline with the steps in the right order.
Ethics committee opinion
We prepare the application and the Finnish or Swedish documents: the summary of the investigation plan, the subject information sheet and the consent form.
Application or notification to Fimea
We compile the application on the MDCG form, send it through Fimea’s secure mail and answer the requests for information.
Site selection and start-up
We negotiate the site agreements and obtain the research permits in hospitals, wellbeing services counties and private clinics, in Finland and in the other Nordic countries.
Monitoring to ISO 14155
Site initiation, monitoring and close-out visits, source data verification, device accountability and follow-up of device deficiencies.
Safety reporting and study close
Serious adverse events and device deficiencies reported to Fimea in the MDCG format, substantial modifications, the end-of-study notification and the investigation report.
None of this stops at the Finnish border. Our internal team handles submissions, research permits and site agreements in the other Nordic countries as well, and has prepared device submissions for Germany. With our wider network of consultant CRAs our reach is broader still.
The order of approvals in Finland
In a drug trial the authority and the ethics committee review side by side. In a device study they come one after the other.
The investigation plan can be in English. Its summary, the subject information sheet and the consent form must be in Finnish or Swedish. Source: Fimea’s instructions, checked in October 2026.
Client story: four device studies
Koite Health’s Lumoral is an oral care device that removes residual plaque with a light-activated method. RecQ Clinical monitors four clinical studies of the device in Finland and Sweden, under ISO 14155 and the MDR.
“The plan we made with RecQ covers every detail the monitor has to take care of.”
Mikko Kylmänen, Project Manager, Koite Health
Why sponsors use a local team
- ISO 14155 certification for device clinical investigations, alongside ICH GCP.
- Finnish- and Swedish-speaking CRAs write and check the participant documents that have to be in the national languages.
- Device experience from joint replacements, stents and stent grafts, transcatheter heart valves, neuromodulation, insulin pumps, robotic surgery and oral light therapy.
- IVD experience that includes companion diagnostic studies run alongside oncology drug trials.
- Studies we have monitored have been inspected by the FDA, BfArM and Fimea.
Questions sponsors ask
Which comes first, the ethics committee or Fimea?
The ethics committee. Fimea requires the opinion as an attachment to the application, so the two reviews cannot run in parallel as they do for drug trials. Build the timeline around that.
Does a study with a CE-marked device have to go to Fimea?
It depends on the purpose of the study and on what the participants go through. A post-market follow-up study that adds invasive or burdensome procedures is notified to Fimea 30 days before the start, and other investigations with a CE-marked device can need an application under Article 82. We check the route against Fimea’s guidance before you commit to a timeline.
Can we submit in English?
The application documents and the investigation plan can be in English. The summary of the plan, the subject information sheet and the consent form must be in Finnish or Swedish.
What if the study also involves a medicine?
Then two sets of rules apply. The drug part goes through CTIS, the device or IVD part to Fimea, and Tukija does the ethics review. In most cases the drug trial is assessed first. Fimea’s Innovation Office gives informal advice on combination studies planned in Finland.
Official sources
- Fimea: Clinical investigations of devices
- Fimea: Performance studies of IVD devices
- Fimea: Combination studies
- Tukija, the National Committee on Medical Research Ethics
How a study runs with us: Clinical trial monitoring and CRA services in Finland · Clinical expertise
Planning a device or IVD study in Finland?
Tell us about the device and your timeline. We reply by the next working day.
