contents table Lexparency.org
Medical Device Regulation (MDR)
ANNEXES

ANNEXES

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