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EU MDR: Touch Your Label Once

Many companies are using the “Touch once” terminology to address the concerns of EU MDR

Medical Device Label Before and After EU MDR – 10 Sticking Points

EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.

EU MDR – Is the industry planning for it? Are you?

Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.

UDI Lessons Learnt. Embrace them for the EU MDR Implementation

The introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance.

EU Medical Device Regulation (MDR) – The Useful Guide to Labeling Compliance

The new regulation is a fundamental revision to better control and identify medical devices products and improve safety and transparency through clear accountabilities, standard processes and data, technological advances and the establishment of an EU database (Eudamed).

Can Vision Systems safeguard label integrity?

Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls.

How one client saved $8M using PRISYM IDs print-on-demand solution

PRISYM ID’s print on demand solution, has enabled this blue chip medical device provider to print single-language Instructions for Use (IFU) at the time of shipment. This means that rather than their manufacturing sites including 23 Language IFUs with the product, they can instead print a country-specific IFU based on the intended destination of each product, and add it to the package at the time of shipment.

Are you ready for UDI?

Medical device manufacturers are up against the clock to ensure they are ready by the 24 September 2016 to meet the FDA UDI compliance deadline.

Survey results show top three labeling challenges

Managing change is a constant challenge. This is particularly true in life science industries where regulatory changes, product innovations and the drive to achieve supply chain efficiencies are ever present.

The Useful Guide to Unique Device Identification

For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However there are some key considerations to be aware of when implementing UDI.

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