EU MDR - Medical Device Labeling Changes & Challenges
These days device labeling has become a critical business process for manufacturing companies, since the manufacturer/marketing authorizing holder need to continuously monitor product safety from PMS and update the label information as applicable.
However, new European Medical Devices Regulation (MDR) brings added complexity and is pushing companies to review their labeling structure and design as they battle for organizational readiness. EU MDR, which began a 5-year pre-implementation period in May 2017, will be fully adopted in 2022. Information provided on a device label is a significant portion of this requirement and should be thoroughly developed and compiled by following the harmonized standards and expert guidance.
Topics covered in this Comprehensive Guide include:
- New Labeling Requirements.
- What does it mean for the sticky label itself.
- Major changes in the device label structure.
- Authorized EU Representatives.
- Labeling design & Strategy.
- MDR timeliness.