The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) each allow a hospital to develop a device or an in vitro diagnostic for use solely in that hospital, but there is no regulatory free pass despite the lack of commercial intent. While the latest guidance on these in-house tests acknowledges that the hospital must determine the degree to which it must comply with the relevant regulation, any hospital that makes and uses an in-house diagnostic or device must develop a risk management mechanism for that device or diagnostic, not an easy lift for entities that may be glancingly familiar at best with conventional regulatory schemes.
In what is claimed as the largest study of how digital technologies were applied to support population level research during the pandemic, scientists at the U.K. Medical Research Council’s epidemiology unit at Cambridge University have reported high, sustained levels of engagement in a fully remote COVID-19 study that ran at a time when visits to a study center were not possible.
Abbvie Inc. and Eli Lilly and Co. Inc. have pulled out of the U.K.’s voluntary pricing scheme for branded drugs in protest at the 26.5% of their revenues they would be required to pay back to the government in 2023.
After years of negotiations, the U.S. FDA and Swissmedic are one step away from recognizing each other’s good manufacturing practice (GMP) inspections of biopharma facilities.
The European Commission is spending €242 million (US$261 million) to create the first rescEU strategic reserve of chemical, biological, radiological and nuclear (CBRN) medical countermeasures.
French consortium Booster is developing a personalized emergency treatment of ischemic stroke in its work on brain clot personalized therapeutic strategies for stroke emergent reperfusion. The aim is to refine the patient prognosis based on blood clot clinical and radiological characteristics and propose more effective drug treatments with a new generation of intracranial stents.
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications.
Transgene SA has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a phase I trial of TG-6050, a novel oncolytic virus (OV) for intravenous administration in patients with advanced non-small-cell lung cancer (NSCLC). Enrollment is expected to open in the first half of this year.
The European Union’s (EU) Artificial Intelligence Act (AI Act) drew a fair amount of criticism when it was first released, but Team-NB, the association of notified bodies (NBs) for the EU, has weighed in with some less than flattering observations. The group’s position paper on the legislation said that the act would not only up-classify some artificial intelligence algorithms to a higher risk class but would also resurrect the backlog of applications because of burdensome new requirements for NBs, thus exacerbating an existing crisis of med tech availability in the EU.
Biontech SE is piggybacking on the U.K.’s lead in implementing cancer genomics in routine health care to set up a national clinical trial of personalized mRNA cancer vaccines that are based on the mutational landscape of individual tumors.
RSS
