EU – New Publication of Harmonised Standards Under the Medical Devices Regulations – April 2025
EU - New Publication of Harmonised Standards Under the Medical Devices Regulations – April 2025
UK – The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
UK - The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
EU – Draft Commission Implementing Regulation Amending Implementing Regulation (EU) 2021/2226 as Regards the Medical Devices for which the Instructions for Use May Be Provided in Electronic Form
EU - Draft Commission Implementing Regulation Amending Implementing Regulation (EU) 2021/2226 as Regards the Medical Devices for which the Instructions for Use May Be Provided in Electronic Form
USA – CDRH Announces Communications Pilot to Enhance Medical Device Recall Program
USA - CDRH Announces Communications Pilot to Enhance Medical Device Recall Program
South Korea – Partial Amendment to the Medical Device Standards
South Korea - Partial Amendment to the Medical Device Standards
South Korea – Draft of Enforcement Regulations of the Digital Medical Products Act
South Korea - Draft of Enforcement Regulations of the Digital Medical Products Act