EU MDR

Five steps to EU MDR-compliant labeling

Susan Gosnell Life sciences, Medical Devices Leave a Comment

The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best …

medical device webinar

Webinar recap: How to comply with medical device UDI requirements

Susan Gosnell Life sciences, Medical Devices Leave a Comment

FDA Class I just the beginning  There is a wave of regulations hitting medical device manufacturers (MDMs) with international operations. In addition to the upcoming deadlines for US FDA Class I and the EU MDR date of application, the in vitro diagnostic regulation (IVDR) date of application goes into effect in May 2022. After that, there are a number of other application …