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Transition to the IVD Regulation – MedTech Europe Survey Results for October 2022
Document paper - Posted on 28.02.2023
MedTech Europe’s position on the Regulation on Standards of quality and safety for substances of human origin intended for human application
Document paper - Posted on 05.12.2022
MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation
Document paper - Posted on 15.07.2022
Recommendations on the use of Guidance Documents Related to the Medical Device Regulation (MDR) and In vitro Diagnostics Regulation (IVDR)
Document paper - Posted on 30.06.2022
Language Requirements for Texts Displayed On IVD Screens and Software
Document paper - Posted on 01.06.2022
Transition to EU IVD Regulation (EU) 2017/746 and considerations for non-EU regulatory authorities on managing the impact to product registrations
Document paper - Posted on 13.05.2022
MedTech Europe information leaflet on UDI and implant card availability
Document paper - Posted on 01.12.2021
Guidance concerning the health rules and importation from Third Countries into the EU of animal by-products and derived products not intended for human consumption
Document paper - Posted on 22.09.2021
MedTech Europe Survey Report – Analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies
Document paper - Posted on 08.09.2021
IVDR: A risk of shortages of tests?
Document paper - Posted on 09.07.2021
Considerations on the current process of harmonisation of standards under the IVD Regulation and Medical Devices Regulation
Document paper - Posted on 06.07.2021
MedTech Europe’s Reflection Paper on the terms of MDR Article 18.3
Document paper - Posted on 24.03.2021
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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.