Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...
To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations, and clinical trial regulations.
The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional ...
GlobalData on MSN2mon
New report reveals ongoing industry challenges around EU’s IVDR and MDR complianceA new report by trade association MedTech Europe has revealed that the struggle for manufacturers to meet the requirements of ...
11monon MSN
However, further research is required. The results are also a success for the MDR & IVDR Competence Center (MIK) of the NMI ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback