Combination Products

The EU commission released a guidance document this week that explains the commission’s policies for transitioning of CE certificates for combination products and for devices manufactured using animal tissues under the medical device regulations. Under the Medical Device Directives and the...

May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources and understand the application of the regulation to their products. Unlike the FDA, the EU does not have clear directions on...