Changing regulations, such as Annex VI clinical trial regulation, need to be incorporated into the label and artwork processes in time for when the regulation takes effect.
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.
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.
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.
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).
Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls.
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.
A 2015 survey carried out by PRISYM ID into the key labeling challenges for the medical device and life sciences industries, has identified regulatory compliance and supply chain efficiency as the key drivers for organizations needing to change or adapt their packaging and labeling operations.
