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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Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

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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Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

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Experience

Founded in 1988, we are among Europe’s largest centres for advisory and representative services. We are proud to have helped over 7,000 manufacturers from over 90 countries address their regulatory challenges.

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We are certified by ISO 9001:2015 and ISO 13485:2016.

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We are members of professional associations and more than 10 European Commission working groups.

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Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.
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