Clinical investigations and performance studies

Clinical investigations

A clinical investigation of a medical device is a systematic investigation involving one or more subjects to assess the safety or performance of a device and may require the approval of the Health Board and/or the medical ethics committee.

The Medical Devices Regulation 2017/745 (MDR) became fully implemented on 26 May 2021. This will lead to a number of changes regarding clinical investigations.

One important change in the MDR is that the legislation specifically describes several types of clinical investigations, including:

• Pre-market clinical investigations, i.e. clinical investigation on devices without CE-marking.
• Post-market clinical investigations, i.e. post-market clinical follow-up (PMCF) investigations. Additional requirements for these studies are in the Medical Devices Act.
• Clinical investigations undertaken for purposes other than those listed in Article 62 of the MDR (see Article 82 of the MDR). Such investigations are regulated in Estonia by the Medical Devices Act.
• Clinical investigations of medical devices without an intended medical purpose (see Annex XVI of the MDR for more information).

Performance studies

From 26 May 2022, the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR) have been implemented.

The IVDR defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of a device. The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing.

The implementation of the IVDR imposes an obligation to apply for authorization of certain performance studies or to notify the competent authority of their initiation.

Authorisation is needed in case of:

• Performance studies for which surgically invasive sample-taking is done only for the purpose of the performance study;

• Interventional clinical performance study - in the IVD legislation this means a study with an in vitro diagnostic medical device where the test results may influence patient management decisions and/or may be used to guide treatment;

• Performance study which involves additional invasive procedures or other risks for the study subjects (even if these are not related to the sample collection);

• Performance studies with companion diagnostics (except when only left‍-‍over samples are used, see below).

Notification required in case of:

• Performance studies with companion diagnostics using left-over samples rather than samples collected specifically for the conduct of the performance study;

• Performance studies with an already CE‍-‍marked device, and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome.

Requirements for clinical investigations and performance studies

Clinical investigations and performance studies will have to comply with all relevant requirements in the regulations 2017/745 and 2017/746, respectively. In addition, there are national requirements for investigations and studies performed in Estonia.

National requirements

In addition to MDR and IVDR, in Estonia investigations and studies concerning medical devices (including in vitro diagnostic medical devices) are covered by the Medical Devices Act.  

The Medical Devices Act requires the sponsor to provide insurance protection for persons participating in the investigation or study in case of personal injuries arising from the investigation or study.

Opinion of an independent ethics committee is also required. The relevant information can also be found in the Medical Devices Act and additionally in a national regulation.

National fees associated with clinical investigations and performance studies

• State fees

According to the State Fees Act § 298¹ state fees applicable to clinical investigation and performance study applications have been established.

Payment of state fees:

Beneficiary's name: Ministry of Finance
Account:
SEB Pank EE891010220034796011 (BIC / SWIFT: EEUHEE2X)
Swedbank EE932200221023778606 (BIC / SWIFT: HABAEE2X)
LHV Bank EE777700771003813400 (BIC / SWIFT: LHVBEE22)
Luminor Bank EE701700017001577198 (BIC / SWIFT: NDEAEE2X)

Reference number: 2900083031

NB! The reference number is mandatory on bank transfer!

• Independent ethics committee fees

Relevant information can be found in the Medical Devices Act § 22.

• Health Board fees

There are fees payable directly to Health Board associated with applications and notifications regarding clinical investigations and performance studies. Relevant information can be found in the Medical Devices Act § 22 and national regulation.

Please contact Health Board directly at [email protected] to apply for an invoice to pay any relevant Health Board fee.

Notifications and other data exchange

Under the MDR and IVDR, applications/notifications for clinical investigations and performance studies, notification of substantial modifications, reporting of serious adverse events and device deficiencies, suspension and resumption of an investigation, and termination of a trial should be notified through EUDAMED. EUDAMED has not reached its full functionality and notifications concerning clinical investigations and performance studies are not possible. 

This means that the above-mentioned exchange of information takes place via the Health Board e-mail [email protected] for the Medical Devices Department.

To submit a clinical investigation or performance study application/notification, prepare the application/notification and documentation according to the MDR or IVDR respectively, pay the relevant fees and submit all required documents to the general e-mail of the Medical Devices Department at [email protected].