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Mashup Score: 0
Receipt of the certificate clears Roche to sell a companion diagnostic for immune checkpoint inhibitors in the European Union.
Source: MedTech DiveCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
Eighty-five percent of respondents said they are implementing the new requirements, finds a survey from Climedo Health and TRIGA-S Scientific Solutions. But most are either familiar or very familiar with the regulations.
Source: MedTech DiveCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 2Notified body shortage remains pressing as industry prepares for staggered IVDR rollout - 2 year(s) ago
Three months have passed since the European Commission warned about a “grave shortage of notified body capacity,” but the situation is largely unchanged.
Source: MedTech DiveCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply - 2 year(s) ago
MedTech Europe welcomed the adoption of the amended transitional provisions, which it said mitigate “the immediate and urgent risk” of disruption.
Source: MedTech DiveCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
The EC’s proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.
Source: MedTech DiveCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 0
European medical device and IVD standards under the current Directives and future Regulations explained
Source: EmergoCategories: Future of Medicine, Latest HeadlinesTweet
.@Roche receives first #Europe #IVDR certificate for #companiondiagnostics | #diagnostics #cancer https://t.co/P9VrMK1q6U