Europe – EU expands use of BioMerieux COVID-19 test
BioMérieux (OTC:BMXXY) announces the expansion of its ARGENE range for the detection of SARS-CoV-2. As a complement to nasopharyngeal swab specimens, the singleplex SARS-CoV-2 R-GENE real-time PCR test...
Europe – Euro Regulatory Roundup
Pandemic-related remote source data verification for clinical trials should focus on critical data, such as the primary efficacy endpoint and key safety measures, according...
Europe – MDCG 2020-16 : Guidance on Classification Rules for in vitro Diagnostic Medical...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – La nouvelle certification CE permettra une plus grande utilisation des dispositifs médicaux...
La certification a toujours été mentionnée comme l’un des obstacles qui ralentissent l’adoption à grande échelle de l’impression 3D – en particulier dans un...
UK – NICE launches consultation on its methods of drug evaluation
The health technology assessment (HTA) agency launched a public consultation last week on a proposal for changes to the methods it uses to evaluate...
Europe – Euro Regulatory Roundup
The European Directorate for the Quality of Medicines (EDQM) has published advice on developing COVID-19 vaccines using viral vector platforms. The text covers analytical...
Europe – Euro Convergence: Experts share advice, concerns and expectations for IVDR
In a panel at RAPS’ Euro Convergence, top experts on the EU In Vitro Diagnostic Regulation (IVDR) discussed the state of the industry just 18 months...
UK – Brexit and the UK’s medical device usability requirements
It is expected the UK and the EU will not agree to retain the regulation of medical devices within a common EU regulatory framework....
Europe – Euro Convergence: Pragmatic approaches to data collection needed to meet MDR
Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under...
Europe – Euro Convergence: Suboptimal use of MDR grace period is storing up trouble
Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity...
