Why The New EU Medtech Regulations Have Caused Chaos And Concern For Combination Products
The EU could be on the point of serious disruption to the regulation of products that combine devices and drugs. The extent of EMA involvement is creating nervousness in the devices industry. In what direction are EU rules headed?
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Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.
Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.