Europe – Study on the implementation of Article 17 of Regulation (EU) 2017/745 on...
Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic...
USA – FDA criticized for approval of genetic test for opioid addiction risk
Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential...
UK – Regulation of devices in Northern Ireland
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.
This...
USA – Medical Device Development Tools (MDDT)
The FDA is announcing the qualification of a new tool through the Medical Device Development Tools (MDDT) program, marking the first-ever qualified database under...
UK – NHS rolls out artificial pancreas in world first move
Tens of thousands of children and adults living with type 1 diabetes across England are set to receive an ‘artificial pancreas’ in a world-first...
Europe – NF EN ISO 20916 – Mars 2024 – Dispositifs médicaux de diagnostic...
Le présent document définit les bonnes pratiques pour la planification, la conception, la conduite, l'enregistrement et l'établissement du rapport d'études des performances cliniques menées...
Europe – Request for a scientific opinion on risks for the health associated to...
Article 51(1) of Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council...
USA – FDA proposes animal study requirements for dental bone grafts
The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using...
USA – Device makers ask FDA for clarification, exceptions to metallic coating guidance
Medical device makers are asking the US Food and Drug Administration (FDA) to make exceptions to its recently proposed guidance on metallic and calcium...
UK – MHRA warns of unsafe counterfeit anti-choking devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not...
