UKCA Marking process support

UKCA Marking services

UK Conformity Assessed (UKCA) marking is now required for medical devices and in vitro diagnostics (IVDs) placed on the Great Britain (England, Scotland, and Wales) market. The transition from CE marking to UKCA brings new regulatory challenges, including compliance with the UK Medical Device Regulations (UK MDR 2002) and engagement with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Our consultants guide you through the UKCA marking process, ensuring a seamless transition and continued market access.

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Navigating UKCA compliance for Medtech companies

Following Brexit, medical device and IVD manufacturers must ensure compliance with UK-specific regulations to continue selling in the British market. While UKCA requirements currently align with the pre-existing EU MDD/AIMDD/IVDD framework, upcoming regulatory changes will introduce stricter rules similar to EU MDR/IVDR.

Our consultants provide strategic and operational support to:

  • Assess UKCA marking applicability and classification for your products.
  • Ensure technical documentation and conformity assessments meet UK regulatory requirements.
  • Assist in interactions with the MHRA and UK Approved Bodies.
  • Provide UK Responsible Person (UKRP) guidance for non-UK manufacturers.
  • Develop post-market surveillance and vigilance processes aligned with UK regulations.

Why use our support for your UKCA Marking process?

Achieving UKCA compliance requires a clear understanding of UK regulatory frameworks and an efficient transition strategy. With our expert regulatory guidance, your company can efficiently navigate UKCA marking requirements, ensuring seamless market access in Great Britain while maintaining compliance with evolving UK medical device regulations.

Our expert support includes:

  • Regulatory Classification & UKCA Roadmap Development – Identifying the appropriate UK regulatory pathway for your device.
  • Technical Documentation & Conformity Assessment – Ensuring compliance with UK MDR 2002 and MHRA expectations.
  • UK Approved Body Support – Assisting with conformity assessments for higher-risk devices requiring third-party review.
  • UK Responsible Person (UKRP) Assistance – Helping non-UK manufacturers establish a compliant UKRP arrangement.
  • Post-Market Surveillance & Vigilance – Developing systems for ongoing compliance with MHRA requirements.
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.