COVID-19
The European Commission (EC), the European body responsible for medical device regulation, published a summary dedicated to the availability and capacity of notified bodies to perform the conformity assessment of medical devices and in vitro diagnostic medical devices...
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework in the sphere of medical devices, issued guidance dedicated to the safety reporting in clinical investigations under the...
EU MDR/IVDR
The European Commission (EC), the EU body focused on the improvement and development of medical devices regulation, issued guidelines describing the way the EU-wide derogations for medical devices should be applied under the Medical Devices Regulation 2017/745 (MDR)....
The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...
