Market Access

UK- UKCA

Expert Guidance for UKCA Certification & UK Market Compliance

With Brexit changing the regulatory landscape, medical device and IVD manufacturers must comply with the UKCA (UK Conformity Assessed) marking requirements to sell their products in Great Britain (England, Scotland, and Wales). Alpine Quality Consultants provides comprehensive consultancy services to help manufacturers achieve UKCA certification efficiently and in compliance with UK MDR 2002 (as amended).

Understanding UKCA Certification for Medical Devices & IVDs

The UKCA marking is mandatory for medical devices and IVDs being placed on the Great Britain market (England, Scotland, Wales). Northern Ireland continues to follow the CE marking under EU regulations.

1. Device Classification under UK MDR 2002

UKCA certification applies to:

  • Medical Devices (Class I, IIa, IIb, III)
  • In Vitro Diagnostic Devices (IVDs) (General IVDs, Self-Test IVDs, Annex II List A & B IVDs)

2. Conformity Assessment Routes

The UK MDR 2002 (as amended) sets out various conformity assessment procedures based on device classification:

Self-Certification (Class I & General IVDs)

  • Manufacturers of Class I devices and non-sterile, non-measuring IVDs can self-certify.
  • A Technical File and Declaration of Conformity (DoC) must be prepared.

Approved Body Conformity Assessment (Class Is, Im, IIa, IIb, III & High-Risk IVDs)

  • Higher-risk devices require a UK Approved Body to conduct a conformity assessment.
  • Quality Management System (QMS) audits and product testing may be required.
  • UKCA Certificate issued by the Approved Body upon successful assessment.

UKRP (UK Responsible Person) Requirement

  • Non-UK manufacturers must appoint a UK Responsible Person (UKRP).
  • The UKRP ensures compliance, registers devices with the MHRA (Medicines and Healthcare products Regulatory Agency), and liaises with authorities.

Our UKCA Certification Consultancy Services

UKCA Readiness Assessment & Gap Analysis

  • Evaluating existing compliance gaps and providing a roadmap to UKCA marking.

Technical File Preparation & Review

  • Assistance in compiling documentation, including risk management, clinical evaluation, and performance data.

Approved Body Selection & Coordination

  • Guiding manufacturers in choosing a UK Approved Body for conformity assessment.

UKRP Appointment & Compliance Management

  • Supporting non-UK manufacturers in selecting and managing a UK Responsible Person.

ISO 13485 QMS Implementation & Audits

  • Ensuring compliance with UKCA regulatory requirements.

MHRA Device Registration Support – Assistance in registering medical devices and IVDs with the MHRA. Post-Market Surveillance (PMS) & Vigilance Reporting – Setting up robust monitoring and reporting systems for ongoing compliance.

Key Documentation for UKCA Compliance

  • Technical Documentation & Design Dossier – Evidence of safety and performance.
  • Clinical Evaluation Report (CER) – Supporting clinical data to prove device efficacy.
  • Risk Management File – Compliant with ISO 14971
  • Post-Market Surveillance (PMS) Plan & Reports – Ongoing monitoring and vigilance compliance.
  • Declaration of Conformity (DoC) – Manufacturer’s declaration of compliance with UK MDR 2002.
  • UKRP Agreement (If Applicable) – Required for non-UK manufacturers.
  • Unique Device Identification (UDI) Compliance – Traceability and device identification.
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