Pharmaceuticals & Medical technology

New medicines and rising costs require clear decisions, for example on reimbursement within the basic health insurance system. Manufacturers, insurers and government all play a key role.

The medical devices sector is also undergoing major change. European regulations such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) impose stricter requirements on manufacturers, distributors, healthcare providers and regulators, particularly in relation to authorisation, transparency and traceability. At the same time, artificial intelligence is gaining ground in healthcare, bringing new regulatory challenges that continue to evolve.

Research remains essential for the development of medicines and medical devices. This requires careful compliance with legislation such as the Medical Research Involving Human Subjects Act (WMO), the Medical Treatment Agreement Act (WGBO) and the Embryo Act. Meanwhile, new frameworks, including the forthcoming Human Tissue Act, are taking shape. The challenge is clear: how do you stay in control in a landscape that continues to evolve?

Legal support across the entire value chain

Our specialists support you at every stage of the value chain – from research and development to production, distribution and use. We advise on compliance and strategy and assist with implementation, for example through contracts, licences and registrations. In doing so, we identify risks early and help you manage them effectively.

We combine sector knowledge with expertise in IP, IT, commercial contracts, employment law and corporate law. Internationally, we collaborate with firms that have strong Life Sciences teams.

Our expertise

• Compliance with legislation and regulations, including the Medicines Act, MDR, IVDR and the AI Act
• Procurement, contracting and preference policy
• Reimbursement and access to insured benefits
• Advertising and inducements
• Liability
• Supervision and enforcement by the IGJ and NZa
• Medical and scientific research

Who do we work for?

We work for healthcare providers, manufacturers, distributors, medical laboratories, contract research organisations and liability insurers.