Europe – EMA to launch scientific advice pilot for high-risk devices in late February

The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – 37 ème organisme notifié au titre du Règlement 2017/745

37 ème organisme notifié au titre du Règlement 2017/745

USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products

The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...

USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability

The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – Dealing with certification gaps (MDCG 2022-18)

Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...

USA – FDA final rule reduces radiological devices reporting requirements

The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....

USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot

Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA)...
MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

UK – MHRA increases UK assessment capacity for in-vitro diagnostic devices

UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices,...

USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...

Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...

USA – FDA draft guidance covers low-level light therapy devices

The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...

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