Labeling Changes & Challenges to Comply with EU MDR
SummaryFor Labeling Challenges accordingly EU MDR introduces additional information that needs to be included on labels, forcing organizations to re-design the label templates.
- Author Company: DDi
- Author Name: kevin smith
- Author Email: email@example.com
- Author Telephone: +18778771519
- Author Website: https://www.ddismart.com/labelai
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.” Read more…