Learn about the European Medical Device Regulations
An initiative by Panton, Holland Innovative, and Fris & Fruitig
The CE Tool explains the application of the new regulations for medical devices, the MDR and IVDR. Is your device or software a medical device and must you comply to the MDR or IVDR? Which class is your medical device? When must it comply with the new regulations? What is the roadmap to certification? Use our quick scans to find out.
Medisch hulpmiddel
Quick scan Medical device
Is your device or software a medical device?
Quick scan Classification MDR
In which class falls your medical device?
Quickscan When MDR
When should your medical device comply to the MDR?
In vitro diagnostisch hulpmiddel
Quick scan Medical device
Is your device or software a medical device?
Quick scan Classification IVDR
In which class falls your medical device?