Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry
Continuing our series of publications, in this briefing we explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services.

 

Continuing our series of publications, in this briefing we explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services.

We also examine progress on the re-designation of the National Standards Authority of Ireland (NSAI),  the only Irish Notified Body in the MedTech space, and the path to approval for medical devices under the new Regulations

Click here or on the image below to download this briefing, or click the following links to view the rest of our series: 

Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry