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Fourteen Notified Body designations to European MDR now entered into NANDO database

Also released were a new list of medical devices and IVDs essential to combating the pandemic, guidance documents, and a browsable database.

The United Kingdom and the European Union are staring down the prospect of beginning the new year without a trade agreement.

Recommendations for more effective virtual medical device, IVD and combination product usability testing to ensure valid results

The impact of the COVID-19 pandemic can be seen in the postponement of the new amendments, as well as in a special discount included in this fiscal year’s fee schedule.

US FDA guidance explains procedures for dealing with 510(k), PMA and other applicants during coronavirus pandemic

The regulatory agency establishes norms regarding advance notice, inspection timeframe, and communications with the medical device establishment.

Understand the different functions of these steps in the human factors engineering design process.

How can companies safely resume in-person usability research and testing during the coronavirus public health emergency?

Second German Notified Body designated to IVDR

Adverse event reporting for FDA EUA-designated medical devices and IVDs

The Center for Medical Device Evaluation (CMDE) published two announcements relating to the filing review process and device up-classification to Class III.

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of...

A robotics project to help children with mobility issues offers practical lessons in human factors engineering (HFE) design.

Other countries that plan to adopt the legislation or align elements of their own regulatory systems with it must now decide how to proceed.