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...
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach regarding cGMP’s and inspections. This new program was released as part of an update to the Compliance Program Guidance...
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...