New medtech regulations

MedTech Europe’s reaction to the President of the European Commission’s State of the Union Address 2026

MedTech Europe responds to stakeholder consultation on the classification of high-risk AI systems

Single-use by design: why reusability should not be the regulatory default under MDR Article 17

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

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

Have a view ?
We want to hear from you