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The use of state-of-the-art standards in the absence of harmonised standards under the IVD and Medical Devices Regulations (IVDR/MDR)

Document - Posted on 17.03.2020

IVDR – MDR Labelling differences: what symbols apply to IVDs

Document - Posted on 14.01.2020

Implementation Status of the Medical Devices Regulation: a Call to Action

Document - Posted on 08.01.2020

Industry Perspective on the Implementation Status of the MDR/IVDR

Document - Posted on 14.06.2019

Healthcare systems across Europe in need of accelerated implementation of the Medical Device Regulation

Document - Posted on 29.05.2019

MedTech Europe position on the proposed draft Standardisation Request for In-vitro Diagnostic Medical Devices (IVD) Regulation (2017/746/EU) and Medical Devices (MD) Regulation (2017/745/EU)

Document - Posted on 29.05.2019

Use of Symbols to Indicate Compliance with the MDR

Document - Posted on 06.05.2019

Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)

Document - Posted on 16.04.2019

Fit-for-purpose approach to biomarker assay deployment in medicinal product clinical trials

Document - Posted on 26.02.2019

Sampling of class B and C IVDs under IVD Regulation 2017/746/EU

Document - Posted on 06.12.2018

Notified bodies – Capacity vs Workload

Infographic - Posted on 31.10.2018

Statement with EFORT on cobalt in orthopaedic implants

Document - Posted on 04.10.2018

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What we work on

MedTech Europe plays an active role in ensuring that patients have access to safe, life-improving technologies. We are committed to making health systems more efficient and sustainable, helping to create a better future together.

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About us

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health.

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About the industry

The medical technology industry is a dynamic and innovative sector working to save and improve lives. With more than 500,000 products and services on the market, medtech companies are improving patient outcomes and helping to make health systems more sustainable.

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