Update – MDR and IVDR implementing measures rolling plan
Posts published in “European Commission”
Unique Device Identification (UDI) System – FAQs
EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay
European implementation of Medical Device and IVD Regulations – Implications for Australia
MHRA guidance updated to reflect the MDR – Clinical investigations of medical devices – Biological safety assessment
BSI – ISO 13485 and products with May 2020 deadline for MDR certification
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Application du règlement européen relatif aux dispositifs médicaux : l’ANSM met en place une phase pilote pour la partie investigations cliniques – Point d’information
UL International (UK) Ltd. (NB 0843) – Medical Device Notified Body Ceasing Operation In the UK
LA AEMPS COMIENZA EL PROCESO PARA SER DESIGNADA COMO ORGANISMO NOTIFICADO DE ACUERDO AL MDR