► Sponsor MedBoard: www.medboard.com
► EUROPE
■ Notified Body overview: [ Ссылка ]
► EU MDR and IVDR consolidated versions
■ EU MDR: [ Ссылка ]
■ EU IVDR: [ Ссылка ]
► Confirmation letter:
■ EU Commission: [ Ссылка ]
► MDCG 2020-3 Significant changes: [ Ссылка ]
► Update Annex XVI timeline: [ Ссылка ]3232054
► EMDN maintenance project launched: [ Ссылка ]
► Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: [ Ссылка ]
► Finland: RoHS is also applicable to Medical Devices: [ Ссылка ]
► Training:
Green Belt Certification Program June 26th until June 30th. [ Ссылка ]
► Switzerland
■ Incident report for economic operators: [ Ссылка ]
■ Incident report for users: [ Ссылка ]
■ Designation of a Vigilance contact person for hospitals: [ Ссылка ]
► United Kingdom
■ New tutorial videos MHRA : [ Ссылка ]
■ New Regulatory Pathway IDAP: [ Ссылка ]
■ Assistive Technology: [ Ссылка ]
■ Report Adverse incidents for Software: [ Ссылка ]
► Rest of the World
■ Australia: Guidance on applying the Advertising Code rules: [ Ссылка ]
■ Canada: Consultation on proposed amendments to the Medical Devices Regulations: [ Ссылка ]
■ India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device : [ Ссылка ]
■ Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: [ Ссылка ]
■ Saudi Arabia Webinar:
Explain The Essential Principles of Safety and Performance for Medical Devices: [ Ссылка ]
Risk Management for Medical Devices: ISO 14971 Requirements [ Ссылка ]
► Podcast
■ Podcast 231: The truth about the UK vs EU situation with Claire Dyson: [ Ссылка ]
■ Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: [ Ссылка ]
■ Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: [ Ссылка ]
■ Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: [ Ссылка ]
► Social Media to follow
■ Monir El Azzouzi Linkedin:[ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]
