The European Association for Medical devices of Notified Bodies (Team-NB) has issued a new guidance...
The concept of ‘at home’ medical devices is certainly not new – medicine spoons, first aid kits and...
Bringing medical devices to market is a process that often takes years. Manufacturers are required...
The European Parliament has voted overwhelmingly to extend transition periods for the Medical...
The new EU Network and Information Systems (NIS 2) Directive entered into force on 16 January 2023....
The MHRA has extended the scope of UL International UK Limited’s approved body designation to...
The regulation of medical device software and apps is a particularly complicated area. Such...
Wireless technology has become a common feature of the medical device industry. From wearables to...
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance on...
Essential requirements are a common feature of medical device regulations around the world. At the...