New medtech regulations

Joint open letter: In anticipation of EUDAMED availability for mandatory use

The Future of Europe’s Medical Technology Regulations

The value of timely interventions in emergency care: IVDs laying the groundwork for urgent care success

Open letter to Commissioner for Health, Stella Kyriakides: Need for comprehensive structural reforms of the medical technology regulatory frameworks

The Manufacturer’s Declaration template is now available on MedTech Europe’s website

Manufacturer’s Declaration in relation to Regulation (EU) 2023/607

MedTech Europe welcomes the adoption of amended transitional provisions of the Medical Devices Regulations and calls for continued work to address outstanding implementation challenges

MedTech Europe calls member states to keep EUDAMED voluntary until it is mandatory to use

Industry data survey shows roadblocks persist to full transition to the IVD Regulation

Transition to the IVD Regulation – MedTech Europe Survey Results for October 2022

Industry data survey shows roadblocks persist to full transition to the IVD Regulation

Publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook

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