Table 9.
Key Characteristics as Central Elements for LDT Regulation in Different Advanced Regulatory Markets.
| No | Element | EU IVDR | U.S | Australia | Canada |
|---|---|---|---|---|---|
| 1 | Quality management system |
Yes ISO 15189 or further national provisions |
Yes CLIA, 21 CFR 820 |
Yes ISO 15189; ISO 17025 ISO 13485 (for class 4) |
Yes (Section 4) |
| 2 | Risk-based approach for classification/categorization |
Yes (4 classes A–D) |
Yes (according to “complexity “and” high/low level risk”) |
Yes (4 classes 1–4) |
No |
| 3 | Risk management system | Yes | Yes | Yes |
Yes (Section 5.4) |
| 4 | Evaluation and documentation related to essential requirements for quality, safety, performance | Yes | Yes | Yes |
Yes (Sections 5, 6, 7) |
| 5 | Product monitoring and surveillance | Yes | Yes | Yes |
Yes (Section 7.4) |
| 6 | Register | No | No | Yes | Not appplicable |
| 7 | Justification for use | Yes | No | No | Not appplicable |
| 8 | Notification requirement | No | Yes | Yes | Not appplicable |
| 9 | Regulatory oversight mechanism | Yes | Yes | Yes | Not appplicable |
For Canada, only the sections of the standard Z316.8-18 are considered. Elements that involve interactions with a regulatory body (e. g. registration, notification etc.) are therefore deemed to be not applicable for Canada. The boxes italic indicate common elements