Table 4.

Clinical evidence requirements for IVDR.

Performance evaluation plan	Annex XIII, part A, 1.1
Performance evaluation report ❒ Scientific validity report ❒ Analytical performance report Clinical performance report	Annex XIII, 1.3.2 ❒ Annex XIII, part A, 1.2.1 ❒ Annex XIII, part A, 1.2.2 Annex XIII, part A, 1.2.3
Final assessment of the clinical evidence	Art. 56.3, Annex XIII, 1.3.1
Clinical Performance studies ✓ Obligatory unless justification can be provided why relying on other sources is sufficient (applicable to self-test and near-patient-test IVDs)	Annex XIII, part A, 1.2.3
Special requirements	Art. 58
Interventional clinical performance studies	Annex XIV
Performance studies on incapacitated subjects	Art. 60
Performance studies in minor subjects	Art. 61
Performance studies on pregnant and/or breastfeeding women	Art. 62
Performance studies in emergency situations	Art. 64