Guidance – Clinical evaluation assessment report template
Posts tagged as “Europe”
Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)Search for available translations of the preceding link
Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
It’s under DG Health now – Medical Devices – Sector
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also…
Conformity assessment procedures for protective equipment
IMDRF Standards Checklist modified in scope of COVID-19
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
EU Public Health Programme 2014-2020
IFA UDI HRI & AIDC Formats IFA Basic UDI-DI ICCBBA Basic UDI-DI ICCBBA UDI HRI & AIDC Formats HIBCC Basic UDI-DI HIBCC UDI HRI &…