USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
On 21 March, an advisory panel to the U.S. Food and Drug Administration gave its unanimous blessing to a piece of wearable technology that...
USA – FDA wants sponsors to test devices that may cause tissue temperature changes
The US Food and Drug Administration (FDA) wants medical device sponsors to test products that may cause changes in tissue temperatures, regardless of whether...
USA – FDA warns consumers against using plastic syringes made in China
It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements,...
Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
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The US Food and Drug Administration (FDA) has released a draft guidance that proposes updating the agency’s final guidance on cybersecurity of medical devices.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...
