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 »
EC Medical Devices Coordination Group meeting to plan the implementation of IVDR
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) met with the European Commission Medical Devices Coordination Group (MDCG) and a number … read more »
Innovate UK sounds alarm on MDR
The UK’s innovation agency Innovate UK has warned that Britain is not ready for implementation of the Medical Device Regulation … read more »
Government publishes guidance on moving goods under the Northern Ireland Protocol
The Government has published guidance for businesses on moving goods to and from Northern Ireland under the Northern Ireland Protocol … 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 »
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 »
