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.