| I | General safety and performance requirements |
| II | Technical documentation |
| III | Technical documentation on post-market surveillance |
| IV | EU declaration of conformity |
| V | CE marking of conformity |
| VI | Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the UDI system |
| VII | Requirements to be met by notified bodies |
| VIII | Classification rules |
| IX | Conformity assessment based on a quality management system and assessment of the technical documentation |
| X | Conformity assessment based on type examination |
| XI | Conformity assessment based on product conformity verification |
| XII | Certificates issued by a notified body |
| XIII | Procedure for custom-made devices |
| XIV | Clinical evaluation and post-market clinical follow-up |
| XV | Clinical investigations |
| XVI | List of groups of products without an intended medical purpose referred to in Article 1(2) |
| XVII | Correlation table |