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

The European Council has given the inexperienced mild to a brand new, harmonised regulation on well being know-how assessments throughout EU member states.

Beneath the EU Health Technology Assessment (HTA) joint scientific assessments and joint scientific consultations on well being applied sciences will probably be enabled between EU member states, to permit for extra fast assessments of healthcare applied sciences.

Key info will probably be shared throughout member states to nationwide well being authorities, which means that just one healthcare know-how evaluation submission at EU degree is required for a particular product from a healthcare know-how firm.

The regulation nonetheless must be adopted by the European Parliament earlier than will probably be printed within the EU Official Journal. It’ll begin to apply three years after its entry into drive (which occurs on the 20th day following its publication).


Well being know-how evaluation evaluates the social, financial, organisational and moral problems with a well being intervention or well being know-how to tell coverage decision-making.

The brand new regulation goals to simplify submission procedures for healthtech corporations and enhance entry to medicines and medical gadgets.

Regulating and harmonising healthcare know-how evaluation throughout EU member states is meant to assist cut back the executive burden on innovators and increase the identification and adoption of protected and efficient healthcare applied sciences by sufferers, healthcare techniques and healthcare professionals.


Trade affiliation Med Tech Europe has been sceptical in regards to the added worth of the HTA. In March the affiliation raised considerations that the brand new regulation might intrude with regulatory assessments carried out below the Medical Device Regulation (MDR), which got here into utility in Might 2021 following a yr’s delay as a consequence of COVID-19.

In a statement on its website, Med Tech Europe CEO Serge Bernasconi, stated: “This regulation will create a brand new regime of joint scientific assessments on medical applied sciences, with out establishing a transparent function for conducting such assessments at EU degree. If future joint scientific evaluation experiences have any probability to actually allow higher affected person entry to medical know-how innovation, will probably be essential to reach at clear and customary floor, with all member states, on the aim for such EU-level work.”


Janez Poklukar, Slovenian minister for well being stated: “The adoption of this legislation is one other demonstration of how EU international locations, when appearing collectively, can obtain very sensible outcomes for his or her residents. This new legislation will profit sufferers, producers of well being applied sciences and our well being techniques.”

Isabel Van De Keere, program director on the Digital Medication Society (DiME), stated: “EU regulators simply took a serious step ahead in direction of the harmonisation of well being know-how assessments throughout EU member states with optimistic implications for healthcare know-how innovators and most of the people in want of protected and efficient well being and care companies. As we noticed all through the pandemic, collaboration between healthcare regulators, coverage makers and healthcare know-how innovators throughout areas is the one means ahead in direction of an accessible, efficient and equitable healthcare system.”

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