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  • R-002-009 Regulatory requirements review report

R-002-009 Regulatory requirements review report

Purpose​

The purpose of this review is to assess new and modified regulatory requirements applicable to Legit.Health's products and services, ensuring ongoing compliance with ISO 13485 and relevant applicable regulatory standards.

Regulatory requirements reviewed​

Period analysed​

July 2024 - December 2024

New or reviewed regulatory requirements​

Regulation/GuidanceNew or reviewed?
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (FDA guidance)New
Global Unique Device Identification Database (GUDID) (FDA guidance)Reviewed
Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (MDCG 2024-15)New
Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2023-3, Rev 1)Reviewed
Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (MDCG 2021-25, Rev 1)Reviewed

Summary of findings and actions plan​

Regulation/GuidanceDateApplicable updatesImpactAction plan
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (FDA guidance)2024-12-03New FDA guidance on design changes management for artificial intelligence-enabled deviceCreation of a Predetermined change control plan as part of the submission documents for FDA approval- Creation of a specific procedure in the QMS to document teh requirements
- Creation of a template for the Predetermined Change Control Plan (PCCP)
- Creation of the PCCP record to be included as part of the FDA submission
Global Unique Device Identification Database (GUDID) (FDA guidance)2024-12-17Updated FDA guidance on the assignation and management of UDI number for devices FDA-approved in the USAssignation of UDI number to FDA-approved devices and its management in the GUDID database. The updated guidance reflects changes to the Global Medical Device Nomenclature (GMDN) field in GUDID database.- Inclusion of updated GUDID requirements in the procedure GP-026 Product requirements for US market
- Assignation and management of UDI number according to the requirements
Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (MDCG 2024-15)2024-11New MDCG guidance published on the topic of the publication of clinical investigations in absence of EUDAMEDThe Sponsor of a clinical investigation shall submit the clinical investigation report and its summary to the competent authority of the Member State in which the clinical investigation was conducted within one year of the end of the clinical investigation or within three months of the early termination or temporary halt. The guidance further describes how the competent authority assigns unique identifier to each clinical investigatio report.Revision of procedure GP-015 Clinical evaluation to ensure the requirement is documented
Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2023-3, Rev 1)2024-11First revision of MDCG 2023-3 on vigilance terms clarificationRevision of vigilance terms. This revision shall be integrated into our procedure for the vigilance system of medical devicesRevision of procedure GP-004 to integrate the revison of vigilance terms
Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (MDCG 2021-25, Rev 1)2024-10Revision of the guidance on placing legacy devices in the marketRevision of requirements and conditions to be met to place legacy devices into the marketRevision of requirements to ensure we fulfil them and that they are properly documented as part of our QMS

Record signature meaning​

  • Author: JD-004
  • Review and approval: JD-001
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R-002-008 Quality and regulatory roadmap
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GP-003 Audits
  • Purpose
  • Regulatory requirements reviewed
    • Period analysed
    • New or reviewed regulatory requirements
  • Summary of findings and actions plan
  • Record signature meaning
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.)