How Authorities Should Communicate Globally About Device Threats
Only those countries signed up to the International Medical Device Regulators Forum are automatic members of the new global communication system for risky devices and IVDs.
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Latest Cybersecurity Guidance From IMDRF Highlights Software Bills Of Materials
In its latest cybersecurity guidance document, the International Medical Device Regulation Forum outlines why medical device manufacturers should ensure that each component of their device is cybersecure and how this can be done.
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.
Annex XVI Products Set To Have More Time To Comply With MDR
Devices without a clinical purpose that fall under the scope of the EU’s Medical Device Regulation need to be tightly regulated. Now it looks as though manufacturers will have more time to comply if they need it.