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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.
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.