Clinical investigation of medical devices
Clinical investigation is defined in Regulation (EU) 2017/745 as any systematic investigation involving one or more human participants, carried out to evaluate the safety or performance of a device. It should be emphasized that this definition includes both the use of devices without CE marking and investigations of devices with CE marking.
Specific articles of the Regulation detail the different types of clinical investigations of devices (CIs):
CIs carried out to demonstrate the conformity of devices - Article 62
This article refers to clinical investigations of experimental devices, carried out for the purposes of conformity assessment, i.e., investigations carried out within the scope of the development of new devices with the aim of obtaining/extending CE marking, which include one or more of the following objectives:
- to establish and verify whether a device is suitable for its intended purpose and achieves the performance intended by the manufacturer;
- to establish and verify the clinical benefits of a device;
- To establish and verify the clinical safety of the device, determine any undesirable side effects under normal conditions of use, and assess whether they constitute acceptable risks when compared to the benefits to be achieved by the device.
The requirements applicable to these clinical investigations are detailed in Articles 62 to 81 of the Regulation, together with Annex XV.
Post-market clinical follow-up (PMCF) investigations - Article 74
When clinical data, relating to the safety or performance of a CE-marked device placed on the market and used within its intended purpose, are obtained through a clinical investigation, this is considered a PMCF investigation.
In such cases, the sponsor must notify INFARMED, I.P. of their intention to conduct the PMCF investigation, and the notification must include the documentation mentioned in Article 74 of Regulation (EU) 2017/745.
Other Clinical Investigations - Article 82
Even if a clinical investigation of devices is not carried out for any of the purposes listed in Article 62 or Article 74, it must comply with certain general requirements set out in Regulation (EU) 2017/745, in particular those relating to the sponsor's responsabilities, ethical aspects and the protection of clinical investigation participants.
Furthermore, clinical investigations conducted in Portugal under Article 82 of Regulation (EU) 2017/745, are subject to specific national provisions. These include requirements on procedures, submission documentation, timelines, fees, opinion of the Ethics Committee, etc., established in Law No. 71/2025, of December 22, the national legal framework for clinical investigations.
