New details from European Commission on Expert Panels under MDR, IVDR

Europe – New details from European Commission on Expert Panels under MDR, IVDR

The European Commission has clarified its designation process for appointing expert panels to support regulators, Notified Bodies and other entities meet requirements and obligations...
CDRH releases Four Final 510(k) Guidances

USA – CDRH releases Four Final 510(k) Guidances

Thursday the CDRH released the following 510(k) guidances : Special 510(k) Program Format for Traditional and Abbreviated 510(k) Abbreviated 510(k) Refuse to Accept Policy 510(k)
EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

Europe – EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices...
EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to...

European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from...
European MDR covers cosmetic and aesthetic products: Are these firms ready?

Europe – European MDR covers cosmetic and aesthetic products: Are these firms ready?

The scope of the European Medical Devices Regulation (MDR) covers not only medical devices but also cosmetic and aesthetic products. Affected manufacturers will have...
Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity

USA – Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity

Anyone paying even the slightest attention to today’s media has likely seen numerous reports on cybersecurity risks associated with medical devices. Some reports are...
FDA issues final guidance on de novo approvals

USA – FDA issues final guidance on de novo approvals

The FDA has released final guidance to clarify exactly what medtech companies need to include in their requests for the agency to review their...
De Novo Requests: FDA Finalizes Three Guidances

USA – De Novo Requests: FDA Finalizes Three Guidances

The US Food and Drug Administration (FDA) on Friday finalized three guidance documents related to de novo classification requests for medical devices. Devices using the...
Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

USA – Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

Ahead of a planned draft guidance on assessing the benefits and risks of new weight-loss devices, the US Food and Drug Administration (FDA) on...
Humanitarian Use Device (HUD) Designations

USA – Humanitarian Use Device (HUD) Designations

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the U.S. Food...

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