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MedTech Europe’s Reflection Paper on the terms of MDR Article 18.3
Document - Posted on 24.03.2021
IVD Symbols Image Files
Infographic - Posted on 22.10.2020
New IVD symbols for compliance with the IVDR
Document - Posted on 22.10.2020
IVD Symbols Titles Translations
Document - Posted on 22.10.2020
Is the IVD Regulation Framework ready for Class D Devices?
Document - Posted on 21.10.2020
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
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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.
About us
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health.
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.