Under the law, the manufacturer of a medical device shall submit to the Icelandic Medicines Agency (IMA) an application for a clinical investigation of a medical device and an application for a performance study of an in vitro diagnostic medical device.

IMA supervises that studies are conducted in accordance with the rules of good practice and legislation on patients' rights, including provisions on research and assessment by the National Bioethics Committee (Vísindasiðanefnd). IMA may halt a study if its conditions are not complied with.

Clinical investigations and performance studies are conducted to confirm that the general safety and performance requirements are met under normal conditions of the intended use of the device. In addition, undesirable side-effects are assessed for medical devices, and performance characteristics for in vitro diagnostic medical devices, together with an assessment of whether the benefit-risk ratio is acceptable.

By definition, clinical investigations are any systematic investigations involving one or more human subjects, undertaken to assess the safety or performance of a medical device. Provisions on clinical investigations and performance studies can be found in Chapter VI of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The parties concerned shall familiarise themselves carefully with these provisions.

The international standard ISO 14155:2026 "Clinical investigation of medical devices for human subjects – Good clinical practice" can be used when conducting studies. The guidance from the European Commission can also be used.

Notification obligation

The obligation to notify investigations or studies under the provisions of the regulations depends on whether the medical device already bears the CE marking and on the purpose of the investigation or study. An authorisation must be sought from the National Bioethics Committee for investigations and studies of medical devices, in accordance with the Committee's detailed guidance.

Contentful
Content missing or inaccessible

When must an application be submitted?

An application must be submitted to IMA if a performance study:

Notification obligation

The obligation to notify investigations or studies under the provisions of the regulations depends on whether the medical device already bears the CE marking and on the purpose of the investigation or study. An authorisation must be sought from the National Bioethics Committee (Vísindasiðanefnd) for investigations and studies of medical devices, in accordance with the Committee's detailed guidance.

Contentful
Content missing or inaccessible

When must an application be submitted?

An application must be submitted to IMA if a performance study:

When must a notification be submitted?

A notification must be submitted to IMA if a performance study:

The image below is from the Medical Device Coordination Group (MDCG) guidance document "MDCG 2025-5 Questions and Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746"

If there is any doubt as to whether a particular investigation or study must be notified to IMA, you can contact IMA and request further information.

Incident reporting

Applications

Applications for clinical investigations and performance studies shall be submitted to IMA via the Contact us portal, after which IMA will request the relevant documents. Once the implementation of EUDAMED has been fully completed, applications for clinical investigations and performance studies will move entirely to EUDAMED. A fee is charged in accordance with IMA's tariff of fees.

Report submission

End of an investigation or study as planned

IMA shall be notified of the end of a clinical investigation no later than 15 days after the investigation ends.

After the investigation ends, a final report shall be submitted to IMA as soon as possible and no later than 12 months after the end of the investigation. The final report shall contain a critical evaluation of all data collected during the investigation.

Investigation or study terminated early or temporarily halted

If a clinical investigation or study has to be terminated early, or an investigation/study is temporarily halted, IMA shall be notified within 15 days and the reason for the termination or halt shall be explained.

If an investigation is halted or terminated for safety reasons, this shall be notified within 24 hours.

If an investigation is terminated early, the final report shall be submitted as soon as possible and no later than 3 months after the termination of the investigation.

The final report shall contain a critical evaluation of all data collected up to the end of the investigation.

Further guidance on preparing the final report can be found in Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. Otherwise, refer to Article 77 of the MDR and Article 73 of the IVDR, as applicable.

Timelines

Further information on the different procedures for clinical investigations and on when IMA's authorisation must be obtained before an investigation begins can be found in Article 70 of the MDR.