Ahead of its introduction on 26 May 2021, here is a practical checklist outlining some of the key elements you should consider to ensure your business operation is fully compliant with EU MDR.
Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls.
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.
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.
LOL and OMG….today everyone knows what these internet slang terms mean and how to use them. You may also be familiar with Medical Device and Life Sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.
