MedTech Dive published an article from Dana Elfin entitled “EU changes for IVDs called a ‘sea change,’ revolutionary”.
https://www.medtechdive.com/news/eu-changes-for-ivds-called-a-sea-change-revolutionary/562811/
https://www.medtechdive.com/news/eu-changes-for-ivds-called-a-sea-change-revolutionary/562811/
... aimed to help notified bodies to deal with new clinical requirements in their assessment and to achieve a better harmonisation among notified bodies thanks to the exchanges. The speakers are Bassil Akra from TÜV Süd, Caroline Dore Geraghty from NSAI and Amie Smirthwaite.
Implementing Act (EU) 2019-1396 - Expert Panels
RMD2019-savethedate-Oct19
https://medtech.pharmaintelligence.informa.com/MT125232/30-Boost-In-EU-MDD-Certificate-Renewals--And-NB-Staffing-Levels-Up-24-In-2018
Team-NB-MD-Sector-Survey-PressRelease-20190524