The European Association for Medical devices of Notified Bodies (Team-NB) has issued a new guidance...
Medical Device Regulations Blog
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 Medical Devices Coordination Group (MDCG) has published guidance discussing the health...
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...
The UK Life Sciences Council has issued a statement concerning their agreement to publish proposals...
Wireless technology has become a common feature of the medical device industry. From wearables to...