First guidance on new rules for certain medical devices
Posts published in February 2019
SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices of 8…
Rare immune-system cancer linked for first time to buttock implant
Regulating medical devices in the event of a no deal scenario
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance Refuse to Accept Policy for 510(k)s
Meetings of MDCG and subgroups – 2019