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EU Notified Bodies proposes steps to tackle MDR, IVDR designation and certification challenges

Swiss regulators develop importation plan for medical devices

Devising clinical development plans (CDP) for clinical evaluation reports and MDR compliance

Reclassification of medical devices with CCS, CNS applications set for November 2021 in Australia

New China NMPA unit will oversee clinical evaluations of medical devices and IVDs marketed in the country

We must consider three elements of completing a task for new users: reading instructions, understanding the task (based on the instructions and device’s design), and performing the task.

New list identifies more than 300 AI/ML medical devices cleared or approved by FDA

India CDSCO publishes risk-based classification lists for six broad medical device categories

Australian regulators ease Conformity Assessment Requirements (CAC) for certain high-risk devices

UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates

Tips for developing effective use scenario prompts in medical device, pharmaceutical and combination product usability testing

BrakTooth cyber vulnarabiltiies for some IoT medical devices in Singapore

Final UDI guidance from Singapore HSA keeps phased implementation timelines in place

Updated China NMPA registration requirements for combination products with drug and medical device components

Key considerations for designing EMR platforms