What does the transition to MDR mean?
Plum Safety’s eyewash products have officially transitioned from the previous MDD (Medical Device Directive) to MDR (Medical Device Regulation). This means that our products have been assessed, documented, and certified in accordance with the EU’s stricter requirements for medical devices. The transition marks a significant improvement in quality and ensures that the products meet the latest requirements for safety, traceability, and documentation. It also ensures that our eyewash products on the market meet much stricter standards for documentation, testing, and ongoing monitoring, which creates greater security and transparency for everyone who uses or distributes Plum Safety products.
What is the difference between MDD and MDR?
The EU MDR introduces stricter rules than the MDD to ensure that medical devices are safer and perform better. The changes in the MDR mean higher safety standards, greater focus on user safety, continuous improvement, and traceability compared to the MDD.
Some of the most important changes are:
- Stricter certification and documentation
- More comprehensive control from notified bodies
- Increased transparency for those who use or evaluate the equipment
New device classifications under the MDR
Plum Safety eyewash products will move from class Is to medical device class IIb, which entails stricter requirements for technical documentation and quality management systems.
Furthermore, the products will be renamed Plum Wound and Eyewash to reflect their expanded intended use and can be used for rinsing eyes, skin, and wounds, which increases the value for you as a distributor and for your customers.
How to spot the difference between MDD and MDR eyewash
- Changed product name
MDD: Plum Eyewash
MDR: Plum Wound and Eyewash - Changed pictograms on label
MDD: can be used in eyes
MDR: Can be used on wounds and eyes
Another way to spot the diffenreces, it that MDR products have:
- Improved traceability through clear marking (batch/lot, UDI and production date)
- Translated into the languages where the product is sold (multi-layer label)
And there are also a higher documentation and quality requirements throughout the product’s life cycle.
