New medtech regulations

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

European medical technology industry calls for the EU to join the Medical Device Single Audit Program as a Full Member

MedTech Europe 2024 Regulatory Survey: key findings and insights

Updated! Medical Device Coordination Group vigilance Q&A document  

MedTech Europe‘s post-EPSCO statement on the necessary reforms of MDR/IVDR

Smooth transition to the mandatory use of EUDAMED

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