Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
ANNEXES
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 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system
VIIRequirements to be met by notified bodies
VIIIClassification rules
IXConformity assessment based on a quality management system and on assessment of technical documentation
XConformity assessment based on type examination
XIConformity assessment based on production quality assurance
XIICertificates issued by a notified body
XIIIPerformance evaluation, performance studies and post-market performance follow-up
XIVInterventional clinical performance studies and certain other performance studies
XVCorrelation table