Developing 2020 Vision: Will Your Labeling Strategy Assure Compliance with EU MDR?
The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of the EU Medical Device Regulation (EU MDR) in 2020.
The first major milestone comes on March 26th 2020 when the EU Database for Medical Devices (EUDAMED) officially goes live, with full application of EU MDR arriving two months later on May 26th. Its impending enforcement presents numerous labeling challenges that could ultimately prevent organizations from being able to sell their products in Europe if they are not addressed.
That’s a 2020 vision that doesn’t bear contemplating. So how can you avoid it? This paper sets out the way forward.