Annex XVI (Non-medical Purpose) - Related International Standards
The following non-harmonised international standards are related to Annex XVI (Non-medical Purpose) for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| Regulation (EU) 2017/745 Annex XVI | List of groups of products without an intended medical purpose referred to in Article 1(2) | active | 1, 2, 3, 5, 10 | Link |
| Regulation (EU) 2022/2346 | Common specifications for products without an intended medical purpose listed in Annex XVI to MDR | active | 1, 2, 3, 5, 10 | Link |
| ISO 14889:2025 | Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses | active | 1, 3, 5 | Link |