European Council gives the go-ahead to new healthtech assessment rules

The European Council has given the green light to a new, harmonised regulation on health technology assessments across EU member states.

Under the EU Health Technology Assessment (HTA) joint clinical assessments and joint scientific consultations on health technologies will be enabled between EU member states, to allow for more rapid assessments of healthcare technologies.

Key information will be shared across member states to national health authorities, meaning that only one healthcare technology assessment submission at EU level is needed for a specific product from a healthcare technology company.

The regulation still needs to be adopted by the European Parliament before it will be published in the EU Official Journal. It will start to apply three years after its entry into force (which happens on the twentieth day following its publication).


Health technology assessment evaluates the social, economic, organisational and ethical issues of a health intervention or health technology to inform policy decision-making.

The new regulation aims to simplify submission procedures for healthtech companies and improve access to medicines and medical devices.

Regulating and harmonising healthcare technology assessment across EU member states is intended to help reduce the administrative burden on innovators and boost the identification and adoption of safe and effective healthcare technologies by patients, healthcare systems and healthcare professionals.


Industry association Med Tech Europe has been sceptical about the added value of the HTA. In March the association raised concerns that the new regulation could interfere with regulatory assessments conducted under the Medical Device Regulation (MDR), which came into application in May 2021 following a year’s delay due to COVID-19.

In a statement on its website, Med Tech Europe CEO Serge Bernasconi, said: “This regulation will create a new regime of joint clinical assessments on medical technologies, without establishing a clear purpose for conducting such assessments at EU level. If future joint clinical assessment reports have any chance to truly enable greater patient access to medical technology innovation, it will be critical to arrive at clear and common ground, with all member states, on the purpose for such EU-level work.”


Janez Poklukar, Slovenian minister for health said: “The adoption of this law is another demonstration of how EU countries, when acting together, can achieve very practical results for their citizens. This new law will benefit patients, producers of health technologies and our health systems.”

Isabel Van De Keere, program director at the Digital Medicine Society (DiME), said: “EU regulators just took a major step forward towards the harmonisation of health technology assessments across EU member states with positive implications for healthcare technology innovators and the general public in need of safe and effective health and care services. As we saw throughout the pandemic, collaboration between healthcare regulators, policy makers and healthcare technology innovators across regions is the only way forward towards an accessible, effective and equitable healthcare system.”

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