The need for technical documentation review by Notified Bodies
The IVDR aims to further strengthen patient safety, while at the same time clarifying and strengthening the powers of Notified Bodies in relation to manufacturers. Under the new IVDR, an estimated 80% of devices are expected to require Notified Body involvement as opposed to 20% under the current directive.
Download and find out how the new regulation will affect In Vitro Diagnostic Device manufacturers including:
- Which classes of devices will be affected
- What this means for IVD manufacturers
- What to include in a customized action plan