European Commission Issues EU MDR/IDVR Implementation Plan
The European Commission issued a new work plan for implementation of EU regulations on medical devices and in vitro diagnostics. Read More
Health Canada Expects Some Devicemakers to Opt Out of MDSAP
Health Canada said some devicemakers may cancel their licenses and discontinue selling their products in Canada rather than conform to the new Medical Device Single Audit Program requirements. Read More
Devices News
FDA Issues Premarket Guidance for Devices With Cybersecurity Risks
The FDA has released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
FDA and DHS Expand Cooperation to Ensure Device Cybersecurity
The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Read More
UK’s MHRA Issues Guidance on How to Comply With EU MDR
Some medical devices that don’t have an intended medical purpose — such as non-prescription colored contact lenses — will be required to comply with the EU’s new regulations for medical devices by May 26, 2020, the UK’s Medicines and Hea... Read More
FDA Hits French Devicemaker for MDRs
Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu,... Read More