Labeling Changes & Challenges to Comply with EU MDR

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Labeling Changes Challenges to Comply with EU
MDR

• The introduction of European Medical Device
  Regulation (EUMDR 2017/745) gives great
  importance to the end user to assist with the
  safe and proper use of a medical device(s). The
  EU MDR and other UDI-type of regulations is
  causing more and more medical device companies to
  revisit their labeling processes. EU MDR
  introduces additional information that needs to
  be included on labels, forcing organizations to
  re-design the label templates that make room for
  data not previously part of the labeling system.
• According to EU MDR.....
• The medium, format, content, legibility, and
  location of the label and instructions for use
  shall be appropriate to the particular device,
  its intended purpose and the technical knowledge,
  experience, education or training of the intended
  user(s). In particular, instructions for use
  shall be written in terms readily understood by
  the intended user and, where appropriate,
  supplemented with drawings and diagrams.

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