More companies will require notified body involvement.

We will examine various device/drug combination products and determine how they are regulated under the EU MDR.
Under the EU MDR, this is the first time that devices that are integral with a drug product will require notified body assessment. Although the requirements are a subset of the full regulation, it will require compliance with the General Safety and Performance Requirements. We’ll also explore guidance that has been issued by European Medicines Agency on Article 117 and how they are interpreting what is an integral device with the medicinal substance. To wrap up we will explore the General Safety and Performance Requirements.

Access the on-demand webinar

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!