CALL TO ACTION: MVP ENTREPRENEURS COMPASS FOR MEDICAL DEVICES REGULATIONS

The medical devices sector is essential to the provision of healthcare to citizens and is an important player in both the European and global economy.

Medical devices play a fundamental and increasing role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users. The regulatory framework evolves and gets more and more complex whilst innovative development in this field still strongly continues.

A mechanism to quickly understand the current legislation; which rule applies to what solution in what context would benefit both innovators and policymakers. It could also ensure that The Netherlands/EU is the best environment to support high potential entrepreneurship and facilitates an environment for taking a lead position with regards to medical devices development cycles.

The call-to-action therefore is to: a) deliver a MVP of a solution for entrepreneurs to easily get an overview of rules that apply to their specific case and get instant updates when changes take place.

And in the longer run the focus could be on next steps such as: b) Build upon insights gained to provide a market feedback loop for policymakers c) Enable testing to measure the impact of new policies.

Interested in this Call to Action?

Contact Tess Rutgers (tessrutgers@gmail.com)