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USA – FDA draft guidance covers low-level light therapy devices

The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...

Europe – Votre avis sur l’extension de la période de transition des RDM et...

La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – Dispositifs médicaux numériques : liste des activités de télésurveillance

Le décret n° 2022-1767 du 30 décembre 2022 décrit les modalités de prise en charge pour les dispositifs médicaux numériques (DMN) de télésurveillance inscrits sur la...

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