Understanding the role of the United Kingdom Responsible Person (UKRP) and the Process for UKCA Marking (UKCA) for Medical Products

The Role of the UK Responsible Person

A UK Responsible Person is a natural or legal person established in the UK who has received and accepted a written mandate from a manufacturer located outside the UK to act on their behalf concerning specified tasks under UK regulations. The UKRP is crucial for non-UK manufacturers as they ensure that the manufacturer's products comply with UK regulatory requirements and act as the primary point of contact for the UK regulatory authorities.

Responsibilities of the UK Responsible Person

1. Regulatory Compliance: Ensure the manufacturer’s products meet all applicable UK requirements.
2. Technical Documentation: Maintain the technical documentation and the UK Declaration of Conformity.
3. Vigilance and Post-Market Surveillance: Cooperate with UK authorities on post-market surveillance and vigilance activities.
4. Incident Reporting: Report any serious incidents and field safety corrective actions to the relevant authorities.
5. Communication: Serve as the primary point of contact between the manufacturer and UK regulatory bodies.

Step 1: Determine the Applicable Regulations and Classification

1. Identify Applicable Regulations: Determine whether the product falls under the UK Medical Device Regulations 2002.
2. Classify the Medical Device: Classify the medical device according to the risk categories defined in the regulations (Class I, IIa, IIb, III).

Step 2: Establish a Quality Management System

1. Quality Management System (QMS): Implement a QMS that complies with the ISO 13485 standard or an equivalent. This system should cover all aspects of design, manufacturing, and quality control.

Step 3: Prepare Technical Documentation

1. Technical File: Compile a technical file that includes detailed information about the product, including design, manufacturing processes, risk management, and clinical evaluation.
2. Clinical Evaluation Report: Conduct a clinical evaluation to demonstrate the safety and performance of the medical device.

Step 4: Conformity Assessment

1. Self-Declaration or Approved Body Involvement: For low-risk devices (Class I), the manufacturer can self-declare conformity. For higher-risk devices (Class IIa, IIb, III), the manufacturer must involve an Approved Body.
2. Approved Body Assessment: The Approved Body conducts an assessment of the technical documentation and the QMS to ensure compliance with the applicable regulations.

Step 5: UK Declaration of Conformity and UKCA Marking

1. UK Declaration of Conformity: Draft and sign a UK Declaration of Conformity, stating that the product complies with the relevant UK legislation.
2. Affix the UKCA Mark: Affix the UKCA mark to the product and packaging, ensuring it is visible, legible, and indelible.

Step 6: Register the Medical Device

1. MHRA Registration: Register the medical device with the Medicines and Healthcare products Regulatory Agency (MHRA).
2. National Competent Authorities: Notify the relevant national competent authorities within the UK.

Transition Period and CE Marking Recognition

Until June 30, 2023, the UK continues to accept CE marked devices for the Great Britain market. However, from July 1, 2023, only UKCA marked devices will be accepted. Manufacturers should plan accordingly to ensure compliance with the new requirements.

Conclusion

The process of obtaining UKCA marking for medical products is comprehensive and requires detailed planning and documentation. Non-UK manufacturers must appoint a UK Responsible Person to facilitate compliance with UK regulations. By following the outlined steps and ensuring adherence to the UK Medical Device Regulations, manufacturers can successfully navigate the UKCA marking process and market their medical products within the United Kingdom.