The European Commission proposed a delay of the MDR and suggested to postpone the date of application for one year due to the current COVID-19 crisis. The Joint Implementation/Preparedness Plan… Read More
Latest MDCG Preparedness Plan and MDR Delay
Month: March 2020
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
The European Commission proposed to exempt certain medical devices and personal protective equipment (PPE) urgently required in the current COVID-19 crisis from regular CE marking requirements. Germany and the UK… Read More
Usability and the MDR
Regulation (EU) 2017/745 on medical devices (MDR) requires manufacturers to fulfill much more specific obligations with regards to usability. It is important to note that these requirements are applicable for… Read More
Update on Notified Bodies
Regulation (EU) 2017/745 on medical devices (MDR) is not even three months away and the designation of Notified Bodies is still behind the expectations of the industry and the announcements… Read More