User interface design and safety issues for medical device designers as home healthcare products become more common

Health Canada published changes to the Medical Devices Regulations (CMDR) that will empower regulatory authorities and place greater emphasis on the life cycle of medical devices.

STeP is modeled after the Breakthrough Devices Program and offers support for medical devices and combination products that aim to improve safety of current treatments and diagnostics.

Obvious use risks posed by medical devices and products must still be mitigated against by product developers and designers

Keeping the user experience centered during the early stages of designing a medical device can help you to optimize healthcare outcomes and avoid use issues down the line.

An updated guidance document extends the deadline for companies to deal with applications and submissions placed on hold during the COVID-19 pandemic, while virtual advisory committee meetings and additional alternatives to on-site MDSAP audits will be available.

The agency plans to maintain continuity and ensure a blend of flexibility and regulatory oversight as it transitions to longer-term transition measures for combating the pandemic.

UK MHRA registration requirements and compliance grace periods for medical devices and IVDs

UDEM becomes eighteenth Notified Body designated under the European Medical Devices Regulation (MDR)

The German organization is now listed in the NANDO database, but concerns remain about whether there will be a sufficient number of Notified Bodies to handle the workload in 2022.

China’s National Medical Products Administration issued a number of new guidelines pertaining to medical device and IVD registration.

Considerations for heathcare providers and other stakeholders involved in vaccine cold chain processes

How Article 59 may allow European market access for urgently needed medical devices without full CE Marking

Australia’s Therapeutics Goods Administration published a regulatory amendment and corresponding guidance on the DoC requirement for low-risk IVDs.

Determining proper human tissue models for medical device usability testing