Europe – New Notified Body Designated Under EU MDR

RISE Medical Notified Body AB Sweden
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Normes Harmonisées 2024/817

La décision d’éxecution (EU) 2024/817 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives à la stérilisation des produits de...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Normes Harmonisées 2024/815

La décision d’exécution (EU) 2024/815 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives aux gants médicaux non réutilisables, à...
Advice for Management of Clinical trials in relation to Coronavirus

UK – New action to tackle ethnic and other biases in medical devices

Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...

USA – FDA official discusses use cases, limits for device PCCPs

While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
Coronavirus delays many FDA foreign inspections

usa – Industry calls for changes in FDA’s RWE guidance for devices

Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for...

USA – FDA official warns device makers over supply chain risks

Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health...

Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...

En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech...

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby...

Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...

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