New medtech regulations

MedTech Europe’s Response to the European Commission’s Proposal for amending the Medical Devices Regulation

MedTech Europe’s position on the Regulation on Standards of quality and safety for substances of human origin intended for human application

Registration is now open for the 22nd IMDRF Management Committee Meeting

MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation

Recommendations on the use of Guidance Documents

EPSCO Council meeting on 14 June 2022

Regulations on IPI and Foreign Subsidies move forward

Recommendations on the use of Guidance Documents Related to the Medical Device Regulation (MDR) and In vitro Diagnostics Regulation (IVDR)

Language Requirements for Texts Displayed On IVD Screens and Software

MedTech Europe welcomes the In Vitro Diagnostic Medical Devices Regulation and urges continued work to deploy the new regulatory system

Transition to EU IVD Regulation (EU) 2017/746 and considerations for non-EU regulatory authorities on managing the impact to product registrations

The IVD Regulation is amended to extend its transitional provisions

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