The proposed regulation covers new medicines and medical devices, providing the basis for pan-EU cooperation on joint clinical assessments. It aims to establish common methodologies and procedures across the EU on joint clinical assessments, focusing on the most innovative health technologies with the most potential impact for patients.
It will also establish joint scientific consultations, and focus on identifying emerging health technologies.
An ageing population and a parallel rise in chronic diseases across the 28 EU countries, along with a rapid increase in innovative medicines, medical devices and diagnostic tools, have put healthcare systems under increasing pressure.
“There will be no additional burden for the med-tech industry (from the proposal),” the EU health Commissioner vowed.