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Performance evaluation and performance studies of IVD-devices

Performance evaluation and performance studies of IVD medical devices

Performance evaluation of IVD medical devices shall follow a defined and methodologically sound procedure for the demonstration of the scientific validity, analytical performance and clinical performance the device. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.

A performance evaluation should follow a defined and methodologically sound procedure for the demonstration of scientific validity, analytical performance and clinical performance, as stated in the Article 56 and Part A of Annex XIII of IVDR ((EU) 2017/746). The performance evaluation and its documentation shall be updated throughout the life cycle of the device.

Performance studies

Performance study means a study undertaken to establish or confirm the analytical or clinical performance of a device. From 26th of May 2022 onwards, all performance studies need to be conducted according to the requirements set out in Article 57 of the IVDR. All performance studies, including performance studies using left-over samples, shall be conducted in accordance with applicable law on data protection.

Notifying performance studies to Fimea

The table below presents the situations in which the sponsor of a performance study shall enter and submit an application following articles 58 or 70 to the Finnish national authority Fimea if the study is to be conducted in Finland. In addition to IVDR, also Finnish Act on Medical Devices (719/2021) Chapter 3 Clinical investigations and performance studies of in vitro diagnostic devices needs to be followed as applicable if the performance study is conducted in Finland.

Study type

IVDR 2017/746 Application / Notification Study start
All performance studies Article 57; annex XIII, part A; Article 68 (3, 4) - -

Performance study,

a) in which surgically invasive sample-taking only for the purpose of the study,

b) that is an interventional(*  clinical performance study

or

c) the study involves additional invasive procedures or other risks (Article 58 (1 a-c))
Articles 57 –77, annex XIII, annex XIV

Application

Immediately after the validation date of application (1a)


After Fimea has notified the sponsor of its authorisation of the study (1 b-c)

Application form, Documents listed in Annex XIII, part A (section 2 and 3) and in Annex XIV. Opinion from a regional ethics committee. 
Performance study involving companion diagnostics (Article 58 (2)) Articles 57 –77, Annex XIII, Annex XIV

Application

After Fimea has notified the sponsor of its authorisation of the study (2)

Application form, Documents listed in Annex XIII (section 2 and 3) and in Annex XIV. Opinion from a regional ethics committee.
Performance study involving companion diagnostics using only left-over samples 
(Article 58 2(2))
Article 57; Annex XIII, osa B; Article 68 (3, 4) Notification at the latest 10 days before starting the study Application form 
Device bearing CE marking is studied within its CE mark and subjects are admitted to procedures additional to those performed under the normal conditions of use of the device (Article 70 (1)) Article 57, Article 58 (5 b–l, p), Articles 71-73, Article 76 (5), Annex XIII, Annex XIV  Notification at least 30 days prior to the commencement of the study Documents listed in Annex XIII (section 2 and 3) and in Annex XIV
Device bearing CE marking is assessed outside the scope of its intended purpose (Article 70 (2)) Article 57, (if needed Articles 58-77, if the requirements are met)

Application if Article 58 applies 

Immediately after the validation date of application (Article 58(1) a)

After Fimea has notified the sponsor of its authorisation of the study (Article 58(1) b-c)

Documents listed in Annex XIII (section 2 and 3) and in Annex XIV. Opinion from a regional ethics committee.

Study that intervenes in the integrity of a human being (719/2021, 17§)

Article 57 a), Article 58 (4; 5 b–m, o; 6–8), Articlet 59–64, Article 68 (1–4, 6) - -

 

Prior to the deployment of the Eudamed database, the applications and notifications shall be submitted to Fimea using Fimea’s Secure Mail Service (https://secmail.fimea.fi/) to cie@fimea.fi (further information about secure mail submissions). 

The official application form will be published shortly. Meantime, please contact Fimea (cie@fimea.fi) to ask for the current version of the form.

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

Other study related notifications

Substantial modifications

If a sponsor intends to introduce modifications to a performance study that is conducted according to article 58 (1,2) or article 70 and the modifications are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, the sponsor shall notify the changes to Fimea within one week. All updated documents should be submitted as appendices with clear marking of the changes made.

Fimea should also be notified if changes are introduced to studies notified to Fimea before 26th of May 2022.

The notifications are done via email cie@fimea.fi. 

Serious Adverse Event and Device Deficiency Reporting

Serious adverse events (death, serious deterioration in the health of the subject,  life-threatening illness or injury) and device deficiencies in performance studies conducted according to Article 58 (1, 2) are reported to Fimea by using the Manufacturer Incident Report (MIR)

In the case of Post-market performance follow-up (‘PMPF’) studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply.
Within performance studies started before 26th May 2022, reporting of SAE and device deficiencies shall be carried out in accordance with the IVDR requirements from 26 May 2022.

End of the study or temporary halt and early termination 

The end of a performance study coincides with the last visit of the last subject unless another point in time for such end is set out in the performance study plan. For performance studies conducted under Article 58 (1,2) or Article 70, a notification of the end of that performance study shall be made to Fimea within 15 days of the end of the study.
If the performance study has been temporarily halted or terminated early, Fimea shall be notified within 15 days. If the temporary halt or early termination has been performed on safety grounds, Fimea shall be informed within 24 hours.

A performance study report shall be submitted to Fimea irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt of the study. The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. 

Notifications related to termination or halt of the performance study and performace study reports shall be submitted via email cie@fimea.fi.

Fees

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

Read more

IVD regulation EI 2017/745, Chapter VI, Clinical evidence, performance evaluation and performance studies + Annex XIII and Annex XIV

Medical Devices Act (719/2021) Chapter 3 Clinical investigations and performance studies of in vitro diagnostic devices

MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)