Terms and definitionsAQ
Clinical trial is an umbrella term used for clinical investigations with medical devices, performance studies with IVD, clinical trials of medicinal products, and clinical trials conducted with other interventions.
A clinical investigation with a medical device is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
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Medical devices, accessories for medical devices, and devices without a medical purpose listed in Annex I of the MedDO are referred to as medical devices in this information sheet.
This information sheet is valid under the new regulation that came into force on 26 May 2021 and it is intended for sponsors of clinical investigations of devices, contract research organisations (CROs), and investigators.
It provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance of clinical investigations.
This document does not cover performance studies with IVDs or clinical trials of medicinal products.
Guidance documents, templates, international conventions
European documents:
- Guidance under the MDR, including guidance document MDCG 2020-10/1, guidance document MDCG 2020-10/2
Standards:
- ISO 14155, Clinical investigation of medical devices for human subjects – Good Clinical Practice
- Other standards that reflect the status of science and technology with regard to the development and manufacturing of medical devices
- International conventions: Declaration of Helsinki, Biomedicine Convention, Additional Protocol by the Council of Europe to the Biomedicine Convention, CIOMs Guidelines, etc.
ISO 14155 standard
Art. 3 to 5 ClinO-MD, Chapters 2 and 4 ClinO-MD; Art. 72 and Annex XV of Regulation (EU) 2017/745
The ISO14155 standard describes 'principles of good clinical practice in the field of clinical investigations of devices'.
For example, it defines internationally recognised terms, describes the content of the necessary documents and the obligations of involved persons.
For clinical investigations involving particularly low risks, certain deviations are possible, particularly for post-market trials.
However, the protection of the participants and data quality and security must not be affected by such deviations.
The sponsor is required to address compliance to the standard and disclose any deviations from the standard.
Applicable procedures
- Category A clinical investigation
- Category C clinical investigation
- Medical Divice Regulations in Canada
- International Consensus Standard for Medical Device Manufacturer
