New medtech regulations

Smarter MDR and IVDR oversight for safer and more innovative medical technologies

EUDAMED reaches a major milestone: mandatory use of the first four modules begins

An improved regulatory framework: what do Europe’s diagnostics need?

New EU rules: more business predictability and transparency in medtech conformity assessment

New EU rules: more business predictability and transparency in medtech conformity assessment

MedTech Europe backs EU device regulation overhaul but asks key changes

MDR/IVDR revision: Building a simpler, more predictable framework for patient access and innovation

MDR/IVDR revision: Building a simpler, more predictable framework for patient access and innovation

EUDAMED onboarding webinars

Implementing Act on Notified Bodies requirements: a pragmatic first step to restore predictability

European Commission’s high-level conference on medical devices: innovation and patient safety

Implementing act on uniform application of the requirements for Notified Bodies (Annex VII)

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