*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 »
UK Medicines and Medical Devices Bill begins passage through Parliament
The main role of the Bill is to replace regulations on medicines and medical devices safety arising from EU Directives, … 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 »
EUnetHTA publish Summer Magazine 2019
EUnetHTA has released its latest magazine in a new interactive online format. In addition to an overview of EUnetHTA and … read more »
LRQA will not maintain Notified Body status under MDR/IVDR
Lloyd’s Register Quality Assurance has announced it will not maintain its EU Notified Body status for medical devices when the … 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 »
