European Flag for health regulations

The New European Regulations on Health Technology Assessments


Developments in health technologies are increasingly impacting patient care and the success of public health systems. While the European Union recognizes that new health technology assessment methods are still required to achieve a healthy balance between access and public health protection, it is unclear how exactly new European regulations will affect the future development of health technologies.
The European Commission expects the new European regulations for health technology assessments to come into force in 2020. This will mean harmonizing the assessment process for all new medicines and medical devices.

The new rules will also require applicants to provide more information on their product’s economic value and its ethical, organizational, social, and legal aspects.

Joint Clinical Assessments: relative clinical effectiveness and relative clinical safety

The Joint Committee on Medical Devices of the European Commission and the European Parliament is currently working on a new proposal for medical device regulation. The proposal aims to improve the quality and efficiency of medical device evaluations by introducing an innovative approach called Joint Clinical Assessments (JCAs).

The idea behind JCAs is to combine the assessment of relative clinical effectiveness and safety and to do so in a coordinated and cost-effective manner. The aim is to reduce the number of clinical studies needed while ensuring that only high-quality data are used for decision-making by health authorities.

Joint clinical assessments would be carried out by independent bodies that would assess whether existing evidence meets regulatory requirements or not. If they do, they may then issue an opinion recommending approval or conditional approval of the product under evaluation. If there is insufficient evidence available to make such an opinion, health authorities can request additional data from manufacturers or conduct their own studies.

Join Scientific Consultations: advice on clinical study designs that generate appropriate evidence

In order to facilitate the process of preparing joint clinical assessments, medical technology companies should, in appropriate cases, have the opportunity to engage in joint scientific consultations with the Coordination Group in order to obtain guidance on the information, data, analyses, and other evidence that are likely to be required from clinical studies.

These consultations may also assist companies in identifying any deficiencies in their application or submission which may require further clarification or provide additional information prior to a final decision being made on their application or submission.
Member States will conduct economic assessments locally.

Member States will conduct non-clinical assessments locally

The five non-clinical assessment domains concern cost and economic evaluation of health technology and its ethical, organizational, social, and legal aspects.

Member must ensure that all HTAs are conducted according to common methodological principles in the new regulations. This allows for consistency across member states so that patients who receive treatment in different countries can access comparable information about the benefits and risks associated with treatments available in their country of residence.

The impact on medical devices

Member States can collaborate on HTA on medical devices classified as class IIb or III and in vitro diagnostic medical devices classified as class D.

However, as evidence may become available after the medical device or the in vitro diagnostic medical device is launched, to allow for their selection for joint clinical assessment at an appropriate time, it should be possible for their assessments to take place after their placing on the market.

Companies should prepare their Value Dossiers now

The regulation is a critical effort towards ensuring that independent assessment of new health technologies by competent authorities can take place more efficiently and more quickly in Europe while preserving the interests of patients, public health and innovation.

As the EU member states begin to implement this new regulation, it will be important for them to engage regularly with health stakeholders, including medical professionals and researchers, to evaluate its impact on the health technology assessments for medical devices.

Hence, it is critical for medical technology companies to immediately plan for developing Value Dossiers for their technologies. It won’t take long before demands for clinical and economic data appear and being prepared for such demands will translate into a competitive advantage in the EU.

Click here to learn more about Value Dossiers.


Exclusively for