Message for Saray: CER PMS section inconsistencies

BLOCKER — CER PMS data contradicts PSUR and response claims

The verification audit (2026-04-06) found three problems in the CER's post-market surveillance section that must be resolved before submission. The Item 3a and 3b responses describe data that does not match what the CER actually says. Additionally, we need your clarification on which PMS report is the relevant one.

Deadline: 2026-04-21

The three problems found

Problem 1: CER says "zero complaints" but PSUR says 7 non-serious incidents

The CER (R-TF-015-003), at lines 968-971, currently states:

• "Zero complaints regarding the safety or clinical performance of the device."
• "Zero Serious Incidents or reportable adverse events."
• "Zero CAPAs related to algorithmic performance or diagnostic failures."
• "Zero FSCAs or product recalls."

However, the PSUR (R-TF-007-003, lines 62-98) documents 7 non-serious incidents in 2023:

• 4 customer complaints (API deserialization, timeout, algorithm performance mismatch x2)
• 3 internal non-conformities (image zoom bias, benign pigmentation scoring, misclassification)

The Item 3a and Item 3b responses both say "7 non-serious incidents and zero serious incidents, CAPAs, or FSCAs." This matches the PSUR, but not the CER.

Question for you: Is the CER wrong (should say 7 non-serious incidents, zero serious), or is the PSUR wrong, or are "complaints" and "incidents" different categories and both are technically correct? We need to align these before submission because BSI will compare the CER against the PSUR.

Problem 2: MDCG 2020-6 § 6.2.2 not cited in the CER

The internal meeting on 2026-04-01 identified MDCG 2020-6 § 6.2.2 as the key regulatory basis for using the legacy device's post-market data as clinical evidence for the transitioning device. The Item 3a and 3b responses both say the legacy market data usage "is grounded in MDCG 2020-6 § 6.2.2."

However, MDCG 2020-6 § 6.2.2 is not cited anywhere in the CER. The CER references MDCG 2020-6 in general terms and mentions legacy device market experience, but does not cite the specific section that authorises this use.

What needs to happen: We need to add an explicit citation of MDCG 2020-6 § 6.2.2 in the CER's PMS section, specifically where it presents the legacy device market experience as applicable clinical evidence. This is the regulatory anchor for the entire legacy-data-as-evidence argument.

Problem 3: CER still uses future tense for PMS activities

The CER at lines 973-979 says:

Line 973: "Moving forward, once the MDR-certified Legit.Health Plus is on the market, the manufacturer will continue to implement a proactive Post-Market Surveillance (PMS) process."

Line 977: "Since this clinical evaluation is performed for the initial CE-mark submission of the device (1st commercialization under MDR), there are currently no retrospective PMCF data or results available for this specific version."

This future-tense framing directly contradicts our strategy of using the legacy device's 4+ years of market experience as current clinical evidence. The CER is saying "we have no market data" in one section while simultaneously referencing 4,500 reports and 21 contracts in another section. BSI will notice this inconsistency.

What needs to happen: Rewrite these paragraphs to acknowledge the legacy device's PMS data as applicable evidence (per the equivalence assessment and MDCG 2020-6 § 6.2.2), while correctly noting that no PMS data yet exists for the specific MDR-certified version.

Question for clarification

The 2026-04-01 meeting identified that we need to prepare "el informe PMS del dispositivo legacy (per MDR Art. 85)" as the main post-market evidence for the CER.

Which PMS report is this?

• Is it the existing R-TF-007-003 PSUR (which already documents the 21 contracts, 4,500+ reports, 7 non-serious incidents)?
• Is it the existing R-TF-007-004 PMS Report?
• Or does a new, separate PMS report need to be created specifically for the legacy device, structured according to MDR Article 85 requirements?

The reason this matters: the responses reference "the legacy device PMS data appraised using IMDRF MDCE WG/N56 Appendix F quality criteria as endorsed by MDCG 2020-6 Appendix I." If the existing PSUR already meets this standard, we can reference it directly. If not, we need to create a new document or update the existing one to include the IMDRF appraisal.

Also: MDR Article 85 specifies what a PMS report must contain for Class IIa/IIb/III devices — a summary of results and conclusions of the analysis of PMS data, a rationale for any preventive/corrective actions taken, and conclusions. Does our current PSUR (R-TF-007-003) satisfy Article 85, or is there a gap?

What the responses currently say

For reference, both the Item 3a response (section 6) and Item 3b response (section covering safety sufficiency) state:

"The equivalent legacy device has generated over 4,500 clinical reports across 21 contracts since 2020, with 7 non-serious incidents and zero serious incidents, CAPAs, or Field Safety Corrective Actions (FSCAs), providing strong real-world confirmation of the device's long-term safety and performance profile. The use of this legacy market data as clinical evidence is grounded in MDCG 2020-6 § 6.2.2, which addresses the use of post-market data from legacy devices in the clinical evaluation of the transitioning device. The data is appraised using IMDRF MDCE WG/N56 Appendix F quality criteria."

This is the text BSI will read. The CER must match it.

Summary of actions needed

Action	Owner	Priority
Clarify: which PMS report is the Article 85 evidence?	Saray	Very High
Clarify: "zero complaints" vs "7 non-serious incidents" — which is correct?	Saray	Very High
Add MDCG 2020-6 § 6.2.2 citation to CER PMS section	Taig (after Saray's clarification)	Very High
Fix CER lines 968-971 to match PSUR incident data	Taig (after Saray's clarification)	Very High
Fix CER lines 973-979 future-tense language	Taig (after Saray's clarification)	High
Confirm PSUR satisfies Article 85 or identify gap	Saray	High