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Ensuring a successful transition to the new IVD Regulation in light of COVID-19

Document - Posted on 09.07.2020

Joint MedTech Europe/ EFPIA White Paper on Companion Diagnostics under the IVDR

Document - Posted on 17.06.2020

The need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19

Document - Posted on 10.06.2020

MedTech Europe’s Guidance on Basic UDI-DI Assignment

Document - Posted on 02.06.2020

Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

Document - Posted on 28.05.2020

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

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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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