Table 6.
Cross-References Between Regulatory Obligations for Manufacture of LDTs According to the EU IVDR and Requirements According to ISO 15189.
| Applicable regulatory obligations according to the IVDR | EU IVDR references to the requirements | Compliance status | Reference to ISO 15189 | |
|---|---|---|---|---|
| Related article | Related annex | |||
| General safety and performance requirements | Article 5 (5) | Annex I | Partial | Sections 5.4, 5.5, 5.6 |
| Quality management system | Article 5 (5) (b) & (c) | Complete | Section 4.2 | |
| Risk management system | Annex I (2, 3, 4 & 5) | Partial | Section 4.14.6 | |
| Performance evaluation | Annex I (9) | Partial | Section 5.5 | |
| Justification | Article 5 (5) (d) | No | ||
| Documentation for compliance | Article 5 (5) (g) | Complete | Sections 4.2.2 and 4.13 | |
| Publicly available declaration | Article 5 (5) (f) | No | ||
| Surveillance system (review of experience) | Article 5 (5) (i) | Complete | Sections 4.8, 4.9 and 4.14, 5.3 | |
| Surveillance system (corrective actions) | Article 5 (5) (i) | Complete | Sections 4.10 and 4.11, 5.3 | |
| Transfer of LDTs | Article 5 (5) (a) | No | ||
| Scale of production | Article 5 (5) | No | ||