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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health version 2.1 (Legacy MDD)
  • Legit.Health US Version 1.1.0.0
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Marketing material MDD Web and IFUs
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
          • Request A: Clinical Data Analysis
          • Request B: Data Sufficiency Justification
          • Message for Saray: PMS data clarifications (updated 2026-04-07)
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
        • completed-tasks
        • Coverage matrix
        • BSI Round-1 Submission: Export Plan
        • resources
        • scratchpad
      • Evidence rank & phases
      • Pre-submission review of R-TF-015-001 CEP and R-TF-015-003 CER
  • Pricing
  • Public tenders
  • Trainings
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 3: Clinical Data
  • Message for Saray: PMS data clarifications (updated 2026-04-07)

Message for Saray: PMS data clarifications (updated 2026-04-07)

Partially resolved after 2026-04-07 internal meeting

The PSUR confusion has been resolved. The PSUR (R-TF-007-003) was an obsolete document using a Class IIa/IIb format that does not apply to the legacy device (Class 1 under MDD). It has been moved to deprecated/. The CER's "Zero complaints" is confirmed correct. The CER PMS section has been rewritten with MDCG 2020-6 § 6.2.2 citation and fixed future-tense language. Item 3a and 3b responses have been corrected to remove all PSUR-sourced "7 non-serious incidents" references.

One item remains open (see below).

Remaining open item: Legacy device PMS report (Class 1 format)​

The 2026-04-07 meeting clarified that the legacy device's post-market report should be a PMS report (Class 1 format per MDR Article 85), not a PSUR (Class IIa/IIb format per MDR Article 86).

The CER now cites the legacy device market experience (250,000+ reports, 21 contracts, zero complaints, zero serious incidents) and grounds this usage in MDCG 2020-6 § 6.2.2. However, BSI may ask to see the actual PMS report as a supporting document.

Question: Does a formal PMS report for the legacy device exist in Class 1 format? If not, does one need to be created before submission? The 2026-04-01 meeting identified "el informe PMS del dispositivo legacy (per MDR Art. 85)" as the main post-market evidence to prepare. Is this done, in progress, or still to do?

What was resolved (2026-04-07)​

  1. "Zero complaints" vs "7 non-serious incidents": The "7 non-serious incidents" came from the PSUR, an obsolete Class IIa/IIb document. The CER saying "Zero complaints" is correct for the legacy device (Class 1).
  2. PSUR deprecated: Moved to deprecated/ folder to prevent LLM confusion.
  3. MDCG 2020-6 § 6.2.2 citation: Added to the CER PMS section.
  4. Future-tense language: CER PMS section rewritten to acknowledge legacy PMS data as current clinical evidence.
  5. Clinical evidence strategy: Confirmed as a combination of (a) literature, (b) equivalence (MC_EVCDAO_2019 only), and (c) new voluntary clinical studies for the Plus device. The 8 studies with the Plus device are NOT PMCF of the legacy; they are new studies. The legacy PMS data IS used as clinical evidence for the current device via equivalence.
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  • Remaining open item: Legacy device PMS report (Class 1 format)
  • What was resolved (2026-04-07)
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