Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-026 Market-specific product requirements
      • SP-026-BR Brazil
      • SP-026-UK United Kingdrom
      • SP-026-US United States of America
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-031 Training Data Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-110 Esquema Nacional de Seguridad
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-600 Equality Planning
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
  • Pricing
  • Public tenders
  • Procedures
  • GP-026 Market-specific product requirements
  • SP-026-UK United Kingdrom

SP-026-UK United Kingdrom

Purpose​

Define the process and requirements for placing the CE-marked software as a medical device on the UK market in compliance with applicable UK regulations.

Scope​

This procedure applies to activities related to registering the CE-marked software as a medical device in the UK and ensuring compliance with UK-specific requirements for post-market activities.

Definitions​

  • UK: United Kingdom
  • MHRA: Medicines and Healthcare products Regulatory Agency
  • FSCA: Field Safety Corrective Actions
  • FSN: Field Safety Notice

Responsibilities​

JD-005​

Ensure legal compliance and regulatory compliance of the medical devices registered in UK.

JD-003​

Organize and manage development resources to achieve compliance with requirements.

JD-004​

Ensures compliance with UK-specific requirements and oversees the registration process.

JD-001​

Approve the procedure and provide with the required resources to perform the activities described on it.

Inputs​

  • UK requirements for placing in the market CE-marked devices
  • UK requirements for post-market activities

Outputs​

  • UK registration of CE-marked devices
  • Compliance with applicable UK requirements

Development​

According to changes to the Medical Device Regulation 2002 and the transition period timelines, manufacurers based outside the UK can place their CE-marked medical devices in the UK market when certain conditions are met:

  • a valid CE mark is available for the device to be registered in the UK
  • compliance with applicable requirements set out in the EU Medical Device Directive (MDD) 93/42/EEC or the EU Medical Device Regulation (MDR) 2017/745
  • appointment of a UK authorised representative
  • registration in the MHRA database

UK authorised representative​

An authorised representative based in UK shall be appointed for all manufactures based outside the UK and a written agreement shall be in place.

The responsibilities of the UK authorised representative are established in the Medical Device Regulation 2002 and include the following:

  • register the device with MHRA
  • ensure that the declaration of conformity and technical documentation have been drawn up
  • keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate
  • in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
  • communicate to the manufacturer any request from the MHRA to provide samples or access to the device, and communicate to the MHRA whether the manufacturer intends to comply with that request
  • cooperate with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
  • immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to the device

Labeling requirements​

UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.

CE mark validity timelines​

Once registered with MHRA, the CE-marked device

  • certified under MDD 93/42/EEC can be placed in the UK market until 30 June 2028
  • certified under MDR 2017/745 can be placed in the UK market until 30 June 2030

Vigilance activities​

Once the medical device is registered with MHRA and it is placed in the market, we have the responsibility, together with our UK authorised representative, to notify MHRA of any adverse incidents and/or field safety corrective action.

Incidents and field safety corrective action will be notified to MHRA according to the timelines established in the sections below and they will be documented, investigated and addressed according to the requirements set out in the procedures GP-004 Vigilance system, GP-006 Non-conformity, Corrective and Preventive actions.

Criteria for incidents to be reported​

Any event which meets all three reporting criteria below is considered an adverse incident and must be reported to the MHRA:

  • an event has occurred. This includes situations where testing performed on the device, examination of the information supplied with the device, or any scientific information indicates some factor that could lead, or has led, to an event;
  • the manufacturer's device is suspected to be a contributory cause of the incident;
  • the event resulted in, or might have resulted, in death or a serious deterioration in state of health of a patient, user or other person

Timelines for reporting an adverse incident​

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:

  • Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware
  • Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware
  • Others: No later than 30 calendar days after the manufacturer became aware

Field Safety Corrective Actions (FSCAs)​

FSCAs are actions affecting devices already distributed and which are taken by a manufacturer in order to reduce the risk of death or serious deterioration in health.

FSCAs should always be communicated to all affected customers using a Field Safety Notice (FSN), see also the process described in the procedure SP-004-001 Product withdrawal.

We should notify the MHRA of FSCAs using the FSCA Report Form and the notification should be made before or when the FSCA action is implemented in the UK.

More details about the FSCA process in the UK are provided in the dedicated guidance: Effective field safety notices (FSNs): guidance for manufacturers of medical devices.

Associated documents​

  • GP-004 Vigilance system
  • SP-004-001 Product withdrawal
  • GP-006 Non-conformity, Corrective and Preventive actions

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
Previous
SP-026-BR Brazil
Next
SP-026-US United States of America
  • Purpose
  • Scope
  • Definitions
  • Responsibilities
    • JD-005
    • JD-003
    • JD-004
    • JD-001
  • Inputs
  • Outputs
  • Development
    • UK authorised representative
    • Labeling requirements
    • CE mark validity timelines
    • Vigilance activities
      • Criteria for incidents to be reported
      • Timelines for reporting an adverse incident
      • Field Safety Corrective Actions (FSCAs)
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)