EU MDR/IVDR
The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices. Regulatory Background The new Commission Implementing Regulation (EU) 2020/1207 is...
EU MDR/IVDR
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...
Europe
The European Commission (EC), the EU authority responsible for medical devices regulation, issued a Q&A conformity document describing the approaches to verifying that medical devices and personal protective equipment (PPE) are allowed to be marketed and uses...
EU MDR/IVDR
The European Commission (EC) has released two new guidance related to the nomenclature of medical devices. CND Nomenclature: Key Points The first document published by the EC describes the “Classificazione Nazionale Dispositivi medicini” or the CND – the official...
Europe
The European Commission has announced the extension of the application period for medical device and in vitro diagnostic device expert panels. It is intended that experts will be able to provide technical and scientific advice in regards to applications and medical...
