IVDR Navigator

Article 56 — Performance evaluation and clinical evidence

Article 57 — General requirements regarding performance studies

Article 58 — Additional requirements for certain performance studies

Article 59 — Informed consent

Article 60 — Performance studies on incapacitated subjects

Article 61 — Performance studies on minors

Article 62 — Performance studies on pregnant or breastfeeding women

Article 63 — Additional national measures

Article 64 — Performance studies in emergency situations

Article 65 — Damage compensation

Article 66 — Application for performance studies

Article 67 — Assessment by Member States

Article 68 — Conduct of a performance study

Article 69 — Electronic system on performance studies

Article 70 — Performance studies regarding devices bearing the CE marking

Article 71 — Substantial modifications to performance studies

Article 72 — Corrective measures to be taken by Member States and information exchange between Member States on performance studies

Article 73 — Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination

Article 74 — Coordinated assessment procedure for performance studies

Article 75 — Review of the coordinated assessment procedure

Article 76 — Recording and reporting of adverse events that occur during performance studies

Article 77 — Implementing acts