European Commission to launch first EUDAMED module
The European Commission (EC) has announced the launch of the first module of EUDAMED, the database for medical devices, on … read more »
*Updated* MDR implementation to be delayed
As the coronavirus pandemic continues, the Directorate General of Health (DG Santé) reports that the European Commission (EC) has proposed … read more »
Joint Implementation/preparedness plan released for MDR
As the full application date of the Medical Devices Regulation (MDR) nears, the Medical Device Coordination Group (MDCG) has released … read more »
EUCOPE raises concerns on MDR and IVDR
As the implementation dates for the new European Regulations near, there are concerns in the industry about the resulting fairness … read more »
Further clarity on MDR as EU aims to ensure availability of low-risk devices
Additional clarity on the status of low-risk medical devices has provided further reassurance to manufacturers that patient access will not … read more »
Pilot phase for the application of EU Medical Devices Regulation
ANSM has set up a “pilot phase” to prepare for MDR. The pilot will simulate the new organisation imposed by … read more »
Slow implementation of MDR and IVDR causing increased likelihood of supply disruptions
Concerns that the MDR and IVDR implementation dates cannot be met are escalating, with only 2 out of 60 notified … read more »
Combination Products: EMA to release Draft Guidelines concerning Article 117 MDR requirements
Products that contain both medicinal products and medical devices pose regulatory challenges, and the EMA plans to consult on the … read more »
Update for virtual manufacturers of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has published an update on their previous guidance for ‘virtual manufacturing’ of … read more »
Q&A released for MDR and IVDR implementation
The European Medicines Agency (EMA) has released its first set of Q&A Guidance Notes regarding the implementation of the Medical … read more »
