The Norwegian Medical Products Agency (NOMA) has designated DNV Product Assurance AS as a notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). DNV Product Assurance AS is also previously designated under the regulation on medical devices Medical Device Regulation (MDR).
IVD devices
IVD devices include, among other things, tests for infections (bacteria, viruses), diabetes, cholesterol, cancer markers and genetic testing. These devices are used to analyse samples from the body, such as blood or tissue, and are essential for making accurate diagnoses and tailoring treatment accordingly.
The designation of notified bodies in Europe is crucial for ensuring sufficient certification capacity for IVD devices.
A key role
- Notified bodies play a critical role in ensuring access to safe and effective medical devices. As an independent third party, the notified body assesses whether devices comply with regulatory requirements before they can be placed on the market and used in healthcare services, says Trygve Ottersen, Director General of NOMA.
Before higher-risk medical devices can be placed on the European market, manufacturers must apply to a notified body for an assessment of the device's compliance with the regulatory requirements for safety and performance. This applies to manufacturers worldwide.
Patient Safety and Innovation
-The fact that Norway now has a notified body for IVD devices is important for promoting patient safety, innovation, and the supply of medical devices. It may also help stimulate growth in the Norwegian health technology sector, says Ottersen.
Notified bodies are designated by national authorities in cooperation with the European Commission. There are strict requirements regarding the notified body’s resources, quality management, organisational structure, and independence.