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 »
European Commission publishes IVDR classification guidance
The European Commission (EC) has published new guidance on In Vitro Diagnostic Regulation (IVDR) classification, alongside justification and examples for … 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 »
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 »
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 »
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 »
Preparations required for the impending implementation date of the Medical Device Regulations
Affixing a CE mark to a medical device is one of the legal requirements of placing a device on the … read more »
