The Future of EU Medical Technology Regulatory System

New harmonised standards for Medical Devices and In Vitro Diagnostics Regulations and EC-EU REP

Smarter MDR and IVDR oversight safeguarding access to safe and 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

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

MedTech Europe submission to the European Commission’s Call for Evidence consultation on the MDR/IVDR simplification reform

Revision proposal is first step towards fixing Europe’s complex Medical Devices & Diagnostics rules

Revision proposal is first step towards fixing Europe’s complex Medical Devices & Diagnostics rules

MedTech Europe calls for dedicated pathways for breakthrough, orphan and paediatric devices

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