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Joint open letter: In anticipation of EUDAMED availability for mandatory use

Document paper - Posted on 18.12.2023

Open letter to Commissioner for Health, Stella Kyriakides: Need for comprehensive structural reforms of the medical technology regulatory frameworks

Document paper - Posted on 15.09.2023

Manufacturer’s Declaration in relation to Regulation (EU) 2023/607

Document paper - Posted on 23.06.2023

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

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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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