5. Conclusions on HTA for Medical Devices and IVDs


Conclusions on HTA for Medical Devices and IVDs

During the technology lifecycle identifying the best time for performing an HTA on a medical technology is critical to assess its full value. Patients, decision-makers, healthcare professionals and industry need to be involved in this process.

HTA also takes it into account new medical technologies that are proven to be safe and efficacious but have limited data on their effectiveness. Clinical and cost effectiveness (as differentiated from efficacy) data are frequently only available after a device has been in use for a period of time.

Decision-makers and HTA bodies in light of the HTA Regulation are held to agree on common and proportional evidence requirements that consider agreed standards of care, contextual factors, acceptance of data, evidence, and studies to demonstrate benefit and outcome measures.