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Why The New EU Medtech Regulations Have Caused Chaos And Concern For Combination Products

 
• By Amanda Maxwell

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?

The EU is at a crossroads now on health care product innovation, particularly where drugs are used in combination with devices and IVDs. There is a concern that unless some of the regulatory hurdles are better managed, and urgently, that EU industry and patients alike are going to suffer.

Article 117

One of the biggest differences under the MDR compared with the directives is the regulation of an integral drug/device combination which is not reusable and...

Devices have become increasingly important when it comes to the drug delivery, and another integral part of this technological progress is artificial intelligence, which is playing an increasingly important role...

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