Notified Body Technical File Review Services

Intertek's Notified Body reviewers provide a high level of expertise within an industry-leading turnaround.

According to the Medical Device Directive (MDD), most medical devices require the approval of a Notified Body before they can bear the CE Mark needed for sale in the European Union (EU). Part of this approval process is a technical file review, during which the Notified Body reviews evidence from the manufacturer that the device is safe and effective.

Our Notified Body can also perform a pre-assessment review of your clinical data. This step is optional, but it is extremely helpful in identifying potential problem areas, increasing your likelihood of meeting the CE Marking requirements on the first attempt. It's a small investment that can pay dividends later, by giving you the opportunity to address any unforeseen concerns early in the review process.

Intertek is dedicated to helping you bring your innovative products to the European market without delay.

Request more information to see how Intertek can help your organization with Notified Body Technical File Review Services.