The regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities to make more timely and informed decisions on the pricing and reimbursement of such health technologies.

EMA will support the implementation of the new piece of legislation in three areas. It will:

• support timely conduct of joint clinical assessments (JCA) by the HTA Coordination Group establishing relative clinical effectiveness and relative clinical safety of a new health technology as compared with new or existing technologies. In this context, EMA will provide relevant information from its own regulatory assessments;
• collaborate with the HTA Coordination Group in paralleljoint scientific consultations (JSC) to give scientific advice to technology developers and facilitate generation of evidence that satisfies the needs of both regulators and HTA bodies;
• exchange information on upcoming applications and future health technologies, both for planning…