USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that...
USA – FDA proposes updates to device cybersecurity guidance
The US Food and Drug Administration (FDA) has released a draft guidance that proposes updating the agency’s final guidance on cybersecurity of medical devices. The update...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
Europe – New Notified Body Designated Under EU MDR
RISE Medical Notified Body AB
Sweden
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...
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...
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...
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Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for...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...