EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory pathway that supports patient access to highly innovative technologies, while maintaining the EU’s rigorous safety and performance standards.

As part of the pilot, manufacturers whose devices are granted ‘breakthrough’ status will benefit from enhanced regulatory support, including priority scientific advice from the medical device expert panels that are overseen by EMA.

Breakthrough designation can be granted to highly innovative medical devices that demonstrate the potential to address unmet medical needs, or that offer substantial advantages over existing technologies. As part of the pilot, manufacturers seeking breakthrough designation can submit a request for an opinion to the medical device expert panels.

The assessment will consider, among other aspects, the degree of innovation and the…