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?

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