Supplying European patients with state of the art medical technology innovation is profiting significantly from the Single European Market. The CE mark provides a single access route for medical technologies, preventing national bottlenecks and waste of resources through redundancies and duplication in national approval.

But the advantages of the European regulatory process are increasingly jeopardized by additional market access hurdles at national level. Budgets for medical technology are under continued pressure and the willingness to look into the medium-to long term benefits of device therapy is lacking.

A particular responsibility in this regard lies with the various national-level payers, who are relying to an increasing degree on Health Technology Assessment (HTA) as a supporting tool for their decision-making. However, payer decision making is still a black box to the medical device manufacturer community.

Payer’s evidence expectations need to be realistic, replacing an almost default request for Randomised Controlled Trials (RCT). Instead, evidence needs should be flexible, depending on a selection of the critical ones amongst the many decision making parameters.

Together with the medical device manufacturers, the Medical Professional Community in Europe has to be part of the consultation processes in a structured and regular way. The expertise of medical scientists as well as practitioners needs to be fully integrated to identify appropriate evidence needs on technology innovations.

HTA institutions need to re-define and widen their role from a provider of evidence to a facilitator and enabler of multi-stakeholder processes. Introducing medical technology innovations in Europe in a meaningful way requires a broader collaboration of stakeholders with a re-defined “HTA 2.0” at its centre.

Finally, clarity on clinical evidence needs to be combined with innovative funding mechanisms for innovations, such as conditional coverage or managed entry schemes. These will allow creating (real world) evidence without unnecessarily depriving patients from the innovation they need.

A Coordinated Access approach does not aim to replace national decision making. Instead, it aims at harmonizing national level processes, ensuring they are transparent, predicable and fair. It also intends to leverage the benefits of European collaboration to the best possible extent – as can be witnessed in the journey of HTA in Europe so far.

We need the commitment of all parties – Payers, Professional Societies, Patients, HTA Community & Medical Device Industry – to turn this Vision into a European Reality.