Regulation of Medicines and Devices

The EU as a Single Market has a role in consumer protection and quality assurance of products and services that are available in the EU. This includes products and services used on a daily basis in health systems, such as pharmaceuticals and medical devices and data management tools such as electronic health records.

Whether this is robots used in urological surgical procedures, diagnostic tests used to detect conditions such as cancer, or therapies used to treat patients, these are all governed by legislation set at European level.

Increasingly, the EU is also supporting member states in decisions on reimbursement for new health technologies too. Therefore, it is important that urologists have a say in this governance process as it impacts the availability of products and devices available to perform urological care. The EAU is a member of the following regulatory working groups at European level:

Whether this is robots used in urological surgical procedures, diagnostic tests used to detect conditions such as cancer, or therapies used to treat patients, these are all governed by legislation set at European level. Increasingly, the EU is also supporting member states in decisions on reimbursement for new health technologies too.

Therefore, it is important that urologists have a say in this governance process as it impacts the availability of products and devices available to perform urological care. The EAU is a member of the following regulatory working groups at European level:

Healthcare Professionals' Working Party | European Medicines Agency (EMA)

Health Technology Assessment Stakeholder Network – list of members - European Commission

Our key partner for providing multi-disciplinary input into the regulatory space is Biomedical Alliance in Europe.

The EAU's presence in the EMA Healthcare Professionals Working Party ensures expert input on urological care in medicine regulation. It strengthens clinical relevance, promotes patient safety, and supports evidence-based decisions. Their involvement bridges real-world practice with policy, enhancing communication and trust between regulators and healthcare professionals.

Topic leads: Anders Bjartell and Vasileios Sakalis

The EAU’s participation in the European Commission’s HTA Stakeholder Network is crucial for ensuring urological expertise is reflected in EU-level health technology assessments, particularly in areas such as cancer and advanced therapies.

Their involvement helps align new innovations with clinical guidelines and real-world practice, promotes fair access to diagnostics and treatments across Member States, and contributes to identifying qualified experts for joint assessments. By advocating for pragmatic policies and supporting evidence-based decision-making, the EAU plays a key role in shaping a more inclusive, effective, and patient-centred approach to evaluating health technologies at the European level.

Topic leads: Anders Bjartell and Peter Paul Willemse

The EAU’s involvement in the medical devices regulatory process is essential to ensure that urological technologies are safe, effective, and clinically relevant. Their expert input helps shape standards for high-risk devices like implants and diagnostics, aligning innovation with real-world practice. EAU participation also strengthens scientific advice to regulators, supports transparent evaluation of clinical evidence, and promotes timely access to life-saving technologies. By representing frontline specialists, the EAU helps bridge the gap between regulatory frameworks and patient care, ensuring that new devices meet the needs of both clinicians and patients across Europe.

Topic leads: Vasileios Sakalis and Thomas Knoll