Medical technologies are tightly regulated in Europe. MedTech Europe engages with regulators, policy-makers and other officials from the Institutions of the European Union (EU) and Member States when they draft legislation on medical technologies.

We believe that through engagement and advocacy we can uphold the best interests of the medical devices and in vitro diagnostics sectors, and thus shape a predictable, sustainable and appropriate regulatory environment.

The two most important regulations for the medtech sector in the EU are the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).  which are currently in the implementation phase.

Market Access

When medical technologies access to markets, it means patients and healthcare professionals can use them, reimbursement is guaranteed, funding is available, and manufacturers are appropriately rewarded for their technology and innovation. Market access is impacted by basic rules for business: the medtech industry needs to adapt to these rules, notably requirements for market authorisation (CE marking) in the EU’s Medical Devices Regulations and the In Vitro Diagnostic Regulations. MedTech Europe’s priority is to ensure that the value of medical technologies is recognised through optimised market access, and timely and appropriate funding. We do this by highlighting the uniqueness of the access models for medical technologies. MedTech Europe also addresses challenges related to funding and reimbursement, health technology assessment (HTAs), public procurement, evidence generation and value demonstration. In addition, we liaise regularly with stakeholders to foster dialogue on issues that have an impact on access to markets.

International Affairs

Medical technologies are used around the world in many different settings. Europe remains a centre of innovation where medical technologies are first deployed and from where they are then exported globally, and MedTech Europe helps them to compete freely and fairly in international markets.

Patient Safety

Patient safety is a critical component of quality healthcare. The medical technology industry is constantly striving to create tools which can help to minimise the risk of injury and infection. 

Market Intelligence

Market information is important for medical technology companies keen to remain abreast of the trends that will impact their business environment. 

Personalised Healthcare

With a combination of an ageing population and pressure on health budgets, European countries need to find ways to reduce the growing burdens on healthcare systems. A targeted approach to the prevention, diagnosis and treatment of disease based on an individual’s profile can make healthcare systems more efficient and effective. 


The medical technologies sector takes its environmental footprint seriously. Our companies consider environmental factors during research and development, manufacturing and the entire lifecycle of their products.