Full text of EU MDR (Medical Device Regulation)
[simple-social-share css="0"]
EU MDR Annexes Annex 5

Annex 5 – CE marking of conformity

  1. The CE marking shall consist of the initials ‘CE’ taking the following form:
    CE marking of conformity - 13485Academy
  2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
  3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
IMPLEMENT ISO 13485 & MDR
BY YOURSELF

SEE HOW IT WORKS

  • Optimized for small and medium-sized companies
  • Costs up to 80% less than using consultants
  • Expert consultations and unlimited email support available
  • Created by Advisera, the leading website for compliance