The long-awaited Brexit is set to take place on December 31st, 2020. This is when Britain will exit the European Union after the 1-year transition period which is currently ongoing. In preparation for the exit, the UK MHRA released a guidance...
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...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...
In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, which was slated for next month. With close to 2 million confirmed cases globally,...
The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 deadline for the full implementation of the EU MDR. The plan addresses the concern that the implementation of the MDR has proven to be...
With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry. Many industry groups and notified bodies have called upon the Commission to postpone the deadline until...
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...
The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical technology startups from a multitude of medical modalities present their cutting-edge innovative technology and their plan for growth to gain strategic partnering and investment. The event...
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...