One of the problems of doing business in the EU is that each member nation has its own more or less unique requirements for clinical trial registration, but the Medical Device Coordination Group may have a solution in the form of a pilot program for harmonized clinical trial registration.
The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.
The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.
Device makers know all too well the hazards of liability where their products are concerned, but those liabilities may soon balloon dramatically in the EU. Two pieces of EU legislation are in development, including the AI Liability Directive, which may have the effect of forcing the defendant in a liability case to prove that its product was not the cause of the alleged harm.
The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.
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.
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.
