New medtech regulations

MedTech Europe response to the consultation on Targeted Evaluation of In Vitro Diagnostic Regulation and Medical Devices Regulation

MedTech Europe response to electronic Instructions For Use (eIFU) regulation revision

The Future of EU Medical Technology Regulatory System

Joint discussion paper on the future governance of medical technologies in Europe

MedTech Europe report on Administrative Burden under In Vitro Diagnostics Regulation and Medical Devices Regulation

Digitalisation of Technical Documentation

Ensuring a smooth implementation and use of the EUDAMED Clinical Investigation and Performance Studies module

Submission of vigilance reports to Notified Bodies under EU MDR & IVDR

Exemption of Routine Blood Draws from Article 58.1(a) of the IVDR

Article 10a MDR and IVDR: Decision guide flowchart

Urgent call for clarity on clinical strategy discussions

Urgent call for clarity on clinical strategy discussions

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