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MDRQ #1673

MDRQ #1545: CHAPTER X FINAL PROVISIONS

MDRQ #1610: Article 123 Entry into force and date of application

ANNEXES

Added by Anonymous over 6 years ago.

Status:
Released
Priority:
Low

Description

ANNEXES

Subissues

MDRQ #1674: I General safety and performance requirementsReleasedActions
MDRQ #1675: II Technical documentationReleasedActions
MDRQ #1676: III Technical documentation on post-market surveillanceReleasedActions
MDRQ #1677: IV EU declaration of conformityReleasedActions
MDRQ #1678: V CE marking of conformityReleasedActions
MDRQ #1679: 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 systemReleasedActions
MDRQ #1680: VII Requirements to be met by notified bodiesReleasedActions
MDRQ #1681: VIII Classification rulesReleasedActions
MDRQ #1682: IX Conformity assessment based on a quality management system and assessment of the technical documentationReleasedActions
MDRQ #1683: X Conformity assessment based on type examinationReleasedActions
MDRQ #1684: XI Conformity assessment based on product conformity verificationReleasedActions
MDRQ #1685: XII Certificates issued by a notified bodyReleasedActions
MDRQ #1686: XIII Procedure for custom-made devicesReleasedActions
MDRQ #1687: XIV Clinical evaluation and post-market clinical follow-upReleasedActions
MDRQ #1688: XV Clinical investigationsReleasedActions
MDRQ #1689: XVI List of groups of products without an intended medical purpose referred to in Article 1(2)ReleasedActions

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