Medical Devices Archives - Page 3 of 9

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical device instructions in electronic form under the scope of the EU’s Medical Device Regulation (EU 2017/745, or the ... Read More...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...

EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical device database intended to serve as a repository for detailed information on medical devices approved under the EU’s Medica... Read More...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently released a document outlining “guiding principles” essential to the development of medical devices using artificial i... Read More...

EU Task Force Offers Clarification of Surveillance Requirements for Legacy Medical Devices

A European Union (EU) task force has issued a document intended to clarify the application of the EU’s Medical Device Regulation (2017/745, also known as the MDR) post-market surveillance requirements to legacy... Read More...

FDA Offers Best Practices for Alerting About Cyberthreats

As concerns about cybersecurity become part of the everyday threat landscape, the U.S. Food and Drug Administration (FDA) is taking steps to help medical device manufacturers educate consumers about cybersecuri... Read More...

FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further support its efforts to facilitate the online submission of 510(k) review requests. The draft guidance, “Electronic Submissio... Read More...

FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized medical devices incorporating software based on artificial intelligence (AI) and machine learning (ML) technologies. Pos... Read More...

UK Seeks Overhaul of AI, Software as a Medical Device

In the wake of its exit from the European Union, the United Kingdom is working to update regulations applicable to medical devices that use software based on artificial intelligence (AI). The UK’s Medicines ... Read More...

UK MHRA Launches Med Device Regulatory Consultation

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a public comment process on issues to be addressed in that country’s medical device regulatory framework. Accordi... Read More...