The EC proposed extending the transitional provisions for certain IVD devices, following adoption of Regulation (EU) 2023/607, announced January 23.
The EC proposal to delay the compliance of IVDs also proposes a gradual roll-out of the European database on medical devices, EUDAMED. The EC proposes that certain modules of EUDAMED would become mandatory before completing all six modules.
We briefly share again the requirements for Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR). Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by May 26, 2024, a quality management system and an agreement with said notified body by September 26, 2024.
Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met.
The UK’s MHRA updated its medical device legislation, which has greatly increased the UK’s current capacity to certify medical devices.
The Thai Food and Drug Administration has moved to reduce regulatory review and approval times for medical device manufacturers
Emergo by UL examines the US FDA Center For Devices and Radiological Health (CDRH) 2023 annual report covering medical device regulatory developments over the past year.
Most medical device use errors are induced by user interface design flaws and not by user ineptitude. Disbelievers need only to observe a few usability test sessions to witness the pattern of repeated use errors that particular UI design flaws can induce if the device has not already been “scrubbed clean” of such flaws.
Designers have leveraged systems thinking and technology expansion to rapidly increase the capability and complexity of our medical device and combination products. However, such developments present a real challenge today: how can we connect apps and system components to deliver products that meet a variety of users’ diverse needs effectively and safely?
