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Clinical evaluation and clinical investigations

Clinical evaluation and clinical investigations

Clinical evaluation

Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device. Clinical data is sourced from clinical investigations, scientific literature and clinical follow-up of the device concerned or from a device for which equivalence to the device in question can be demonstrated. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.

According to the EU Medical Devices Regulation (EU) 2017/745, manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in this EU Regulation, including post-market clinical follow-up. Clinical evaluation is thus mandatory for all products. 

The manufacturer shall specify the intended purpose of the product, which shall be specified in the clinical evaluation.

Manufacturers shall perform clinical evaluation in accordance with the requirements set out in Article 61 and Part A of Annex XIV, including post-market clinical follow-up.

The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's post-market clinical follow-up plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

Clinical investigations

Clinical investigations notified before 26 May 2021 
Clinical investigations initiated in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC before 26 May 2021 may be continued as planned.

However, any serious adverse events and device deficiencies that occurred during the study must be reported in accordance with Regulation 2017/745 as of 26 May 2021.

Clinical investigations notified as of 26 May 2021 when Eudamed is not fully functional
The corresponding provisions of Directives 90/385/EEC and 93/42/EEC will continue to apply until Eudamed is fully functional.

However, it is possible to submit a clinical investigation notification in accordance with the application documents pursuant to Regulation 2017/745 as of 26 May 2021.

Any serious adverse events and device deficiencies that occurred during the trial shall be reported in accordance with Regulation 2017/745 as of 26 May 2021 as instructed in MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 May 2020.

Notifying clinical investigations to Fimea

Apply for a permission or notify a clinical investigation 
In the case of a clinical investigation with a non-CE marked medical device or a clinical investigation with a CE-marked device outside the scope of its intended purpose, a permission for the clinical investigation shall be applied from Fimea. The clinical investigation notification procedures pertain to additional evaluations within the scope of the intended purpose of a CE-marked medical device and substantial modifications to a clinical investigation.

Processing of applications and notifications
Prior to the deployment of the Eudamed database, the applications and notifications shall be submitted to Fimea.

The opinion of the Ethics Committee is required before submitting an application or notification and initiating an investigation.
On the date of validation, Fimea’s notification on whether the clinical investigation falls within the scope of the Regulation and whether the application contains the required documents will be sent to the sponsor.

Immediately after the date of validation of the application, some of the clinical studies/investigations may be commenced, while for some of the studies, evaluation of the application will be carried out within 45 days of the date of validation if the deadline is not extended.

The notification pursuant to Article 74(1) shall be made 30 days prior to the commencement of the clinical investigation.
The notification pursuant to Article 74(5) shall be made within one week of a substantial modification to a clinical investigation.

Q & A: MDCG 2021-6, Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

A notification of a clinical device investigation shall be submitted using Fimea’s Secure Mail Service (https://secmail.fimea.fi/) to cie@fimea.fi (further information about secure mail submissions). 

Changes to documents, responses to requests for additional information, substantial amendments to clinical investigations and protocols, as well as final reports, shall also sent by e-mail to cie@fimea.fi.

The maximum size of a message with attachments sent using the Secure Mail service is 50 MB. If the message size exceeds 50 MB, the secure mail service will notify of a transmission failure. In such a case, the material to be sent can be divided into several different messages that are clearly indicated as being interrelated. The maximum size of a message with attachments sent using other mailboxes is 10 MB.

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

The processing fee for a notification concerning the conduct of a clinical investigation is
- €700 for class A products
  (the lower risk class or product class I)
- €1,750 for class B products
  (the higher risk class or product classes IIa–III)

Read more

Clinical investigations conducted with medical devices - Fimea 1/2022

Finnish Standards Association
SFS ry

National Advisory Board on Social Welfare and Health Care Ethics
ETENE

National Committee on Medical Research Ethics
TUKIJA