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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The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.
EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.
Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.