Clinical investigation

In the EU, clinical investigations for conformity assessment follow MDR Articles 62 to 82 and ISO 14155. In the US, the 21 CFR definitions decide when human subject protection and IRB rules apply.

‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

EU MDR, Article 2(45)

Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

21 CFR, 50.3

Clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.

21 CFR, 56.102

systematic investigation in one or more human subjects (3.50), undertaken to assess the clinical performance (3.11), effectiveness (3.20) or safety of a medical device (3.34) Note 1 to entry: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical investigation”.

ISO 14155:2020, clause 3.8

The MDR definition covers any systematic investigation with human subjects to assess a device's safety or performance. The 21 CFR 50.3 and 56.102 definitions describe an experiment with a test article and human subjects and tie it to FDA's submission requirements, whether or not prior submission to FDA is needed.