Clinical investigations of devices

Clinical evaluation and clinical investigations

Clinical investigations

According to Regulation (EU) 2017/745, ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device. The requirements set out in Chapter I of Annex XV to the MDR apply to all clinical investigations of medical devices. 

Fimea must be notified of all clinical investigations conducted with medical devices that fall under the MDR. You must apply to Fimea for authorisation for most investigations. Some investigations are processed through a notification procedure.

  • If the clinical investigation is conducted with a non-CE marked medical device or with a CE-marked medical device outside the scope of its intended purpose AND the results of the investigation will be used in the conformity assessment, you must apply to Fimea for authorisation of the clinical investigation under Article 62 of the MDR.
  • If the results of the investigation will not be used in the conformity assessment of the investigational device (e.g investigator-driven research using a CE-marked device or an early pilot phase investigation with a non-CE marked device), you must apply to Fimea for an authorisation under Article 82 of the MDR. More detailed provisions on investigations under Article 82 have been set out in the Act 719/2021 and Fimea’s Administrative Regulation 1/2022.
  • In the case of a post-market follow-up investigation involving additional invasive and/or burdensome procedures, you must notify Fimea of the investigation under Article 74(1) of the MDR. If the description given in Article 74(1) does not apply, the investigation may be in accordance with Article 82. 

You can find more information about different regulatory pathways in document: MDCG 2021-6.

Clinical investigations of devices