Month: February 2020

New guidance documents for EMDN and cybersecurity

February 13, 2020

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

The European Commission has issued new guidance documents on the new nomenclature system EMDN that manufacturers must use under the Medical Devices and IVD Medical Devices Regulation (EU) 2017/745 and… Read More

Brexit and the regulatory situation for the medtech industry

February 3, 2020

by Sheila OShaughnessy

31 January 2020 was a somewhat significant day as the UK formally left the EU at a strategic point in the implementation of the Medical Devices and IVD Regulations (EU)… Read More

Month: February 2020

New guidance documents for EMDN and cybersecurity

Brexit and the regulatory situation for the medtech industry

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

European Commission publishes Q&A guidance on COVID-19 tests