White Papers
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10 Steps To EU MDR Labeling Implementation
4/22/2019
The European medical device industry is in the grip of the biggest change the market has seen in decades and the European Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, a manufacturer or supplier will need to adhere to the new EU MDR. This white paper presents 10 steps required to make the implementation of EU MDR labeling simpler.
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Will Your Labeling Strategy Assure Compliance With EU MDR?
4/22/2019
The new regulation, which entered into force in May 2017, imposes major new rules on companies involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. Will your labeling strategy assure compliance With EU MDR?
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EU MDR Labeling Compliance: Learning The Lessons From UDI
4/22/2019
As organizations struggle to meet the challenges of EU MDR, there are many lessons to be learned from the UDI experience. This paper presents those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations.