IGeneral safety and performance requirements
IITechnical documentation
IIITechnical documentation on post-market surveillance
IVEU declaration of conformity
VCE marking of conformity
VIInformation 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
VIIRequirements to be met by notified bodies
VIIIClassification rules
IXConformity assessment based on a quality management system and assessment of the technical documentation
XConformity assessment based on type examination
XIConformity assessment based on product conformity verification
XIICertificates issued by a notified body
XIIIProcedure for custom-made devices
XIVClinical evaluation and post-market clinical follow-up
XVClinical investigations
XVIList of groups of products without an intended medical purpose referred to in Article 1(2)
XVIICorrelation table