MHRA
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active...
MHRA
The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how...
EU MDR/IVDR
The Compliance and Enforcement Group (COEN), an EU body focused on the sphere of information exchange between market surveillance authorities and coordination of enforcement activities, has issued a checklist dedicated to the instructions for use (IFU) for reusable...
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...
