Medical Devices → United Kingdom

Facilitating Market Access in the UK Medical Devices Sector

Post‑Brexit, the United Kingdom now operates its own medical devices regulatory framework distinct yet partially aligned with previous EU structures. While still aligned in many ways with the former EU system, UK-specific requirements, such as registration with the MHRA, appointment of a UK Responsible Person, and conformity to UKCA marking, present new challenges for manufacturers aiming to supply the British market. 

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UK Responsible Person

MHRA Device Registration

UKCA Marking Guidance

Certification of Free Sales

Approval Body Selection

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United States

The United States is the world’s largest and most lucrative medical device market, offering vast opportunities but demanding rigorous FDA compliance for market entry.

European Union

The European Union medical device market, serving over 500 million patients, offers vast opportunities but requires strict compliance with Regulation (EU) 2017/745 (MDR).

Switzerland

Switzerland’s medical device market is innovation-driven and closely aligned with EU standards, but requires non-Swiss manufacturers to meet national obligations.

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