4. Post-Market Layer
4.1 Vigilance Log
What this module is, in one paragraph. Post-market vigilance is the regulator-enforced discipline of reporting serious incidents and Field-Safety Corrective Actions (FSCA) within strict deadlines. MDR Art. 87 mandates 2 calendar days for serious public-health threats, 10 days for death or unanticipated serious deterioration in health, 15 days for other serious incidents — measured from the date the manufacturer becomes aware. FDA 21 CFR 803.50(a)(1)–(2) mandates 30-day MDRs for death / serious injury / malfunction likely to recur, and §803.53 mandates 5-day reports for events requiring remedial action to prevent public-health threat. FDA 21 CFR 806.10 mandates reports of corrections and removals. MDR Art. 88 mandates trend reports for statistically significant increases in non-serious incidents. MDR Art. 86 mandates PSUR annually for Class IIb/III/Implants, every 2 years for Class IIa, with submission to NB via EUDAMED for Class IIb/III. MDR Art. 89 + Annex XIV Part B mandate PMCF reports. Wrapper’s Vigilance Log enforces every clock from the moment an incident is logged, exposes red/amber/green progress bars, links every event to a UDI, produces MIR (MDR Art. 87) and FSCA documents, schedules and tracks all periodic reports.
Regulatory pathway summary. Supports MDR Chapter VII Section 2 vigilance (Arts. 87, 88, 89, 90, 91, 92) reporting to competent authorities via EUDAMED Vigilance Module; FDA Medical Device Reporting under 21 CFR 803 (§803.50 30-day, §803.53 5-day, §803.56 supplemental) including MedWatch 3500A; FDA Reports of Corrections and Removals under 21 CFR 806; UK MDR 2002 Part IV vigilance.
| Purpose | Track every post-market event from initial signal through reporting and follow-up with the regulatory clock visible at all times. |
| What the user sees | Dashboard with red/amber/green clock counts, open MIRs, FSCA in flight; three log tabs (Incidents & MIR, FSCA & Corrections, Periodic Reports — PSUR / PMCF / Trend). Reporting clocks shown as progress bars. |
| What it replaces | The "complaint → CAPA → maybe-vigilance" pathway where the regulatory clock is not enforced. |
| Regulatory frameworks | MDR Arts. 87, 88, 89, 90, 91, 92; FDA 21 CFR 803.50/.52/.53/.56; FDA 21 CFR 806.10; UK MDR 2002 Part IV; MDCG 2023-3 vigilance terms. |
| Solves the regulatory problem of | MIR not filed within MDR Art. 87(3) 15-day window — competent-authority Art. 93 enforcement, potential CE suspension; FDA 30-day MDR breach — Form-483 + Warning Letter; FSCA not reported per Art. 89(8) — Member-State enforcement under Art. 95. |
| Pathway milestone unlocked | EUDAMED Vigilance Module submission readiness (Q3 2026 mandate); MDR Art. 86 PSUR submission to NB triggering surveillance-audit Class IIb/III renewal; FDA 21 CFR 803 annual MDR compliance; MDSAP Chapter 7 evidence. |
Regulatory Specificity
Table 1 — Which regulation applies in which case
| Feature | Citation | Applies when… | Class |
|---|---|---|---|
| 2-day MIR clock | MDR Art. 87(4) | "Serious public-health threat" event | All classes |
| 10-day MIR clock | MDR Art. 87(3) first indent | Death or unanticipated serious deterioration in health | All classes |
| 15-day MIR clock | MDR Art. 87(3) second indent | Other serious incident | All classes |
| FDA MDR 30-day | 21 CFR 803.50(a)(1)-(2) | Death / serious injury / malfunction likely to recur | FDA Class II, III |
| FDA MDR 5-day | 21 CFR 803.53 | Event requiring remedial action to prevent public-health threat | FDA Class II, III |
| FDA MDR supplemental | 21 CFR 803.56 | New information on previously-reported event | FDA Class II, III |
| FSCA reporting | MDR Art. 89(8); 21 CFR 806.10 | FSCA initiated | All classes |
| FSN publication | MDR Art. 89(8) + MDCG 2023-3 | FSCA executed | All classes |
| Trend reporting | MDR Art. 88 | Statistically significant increase in non-serious incidents | All classes |
| PSUR Class IIa | MDR Art. 86(1) | Biennial cycle | IIa |
| PSUR Class IIb/III/Implants | MDR Art. 86(2) | Annual, submitted to NB via EUDAMED | IIb, III, Implants |
| PMS Report Class I | MDR Art. 85 | Annual cycle | I |
| PMCF report | MDR Annex XIV Part B + Art. 86(2) | PMCF plan executed | IIa, IIb, III |
| Recall classification (I/II/III) | 21 CFR 7.3(m); 21 CFR 806 | FDA-jurisdiction recall | FDA Class II, III |
| MedWatch 3500A export | 21 CFR 803.52 | FDA manufacturer MDR submission | FDA Class II, III |
| UDI on incident | MDR Art. 87(5); 21 CFR 830.300 | All vigilance submissions | All classes |
| Authority communications log | MDR Art. 92 (cooperation with CA) | Every CA exchange | All classes |
| UK Vigilance | UK MDR 2002 Reg. 44–44E | UK-marketed devices | UK scope |
Table 2 — Regulatory problem solved
| Feature | Concrete pain point |
|---|---|
| 2-day clock progress bar | Serious public-health-threat event missed the 2-day window — Art. 93 CA enforcement; CE certificate suspension. |
| 10-day clock progress bar | Death event missed 10-day window — same enforcement track. |
| 15-day clock progress bar | Other-serious-incident missed 15-day window — competent-authority Art. 93 enforcement. |
| FDA 5-day clock | Public-health-threat MDR missed — Form-483 + Warning Letter. |
| Trend report flag | Cluster of non-serious events not detected — Art. 88 trend-reporting failure. |
| PSUR cycle tracker | Class IIb PSUR overdue → NB blocks surveillance-audit close-out → CE certificate at risk. |
| UDI on every event | MIR rejected by EUDAMED for missing UDI — re-submission cost. |
| Authority communications log | NB asks "show me your last 12 months of CA exchanges" — answered in one screen. |
| Recall classification | FDA recall not classified I/II/III — §806.10 finding. |
| MedWatch export | FDA MDR submitted in wrong format — refusal-to-accept. |
Table 3 — Conformity-assessment pathway impact
| Feature | Pathway / milestone unlocked |
|---|---|
| Vigilance clocks live | EUDAMED Vigilance Module readiness (Q3 2026); MDR Art. 87 compliance |
| PSUR cycle | MDR Art. 86 PSUR submission; Class IIb/III NB surveillance close-out |
| FSCA / FSN | MDR Art. 89 + MDCG 2023-3 evidence |
| MedWatch export | FDA MDR submission acceptance |
| Recall classification | FDA §806 inspection readiness |
| Authority communications log | NB Annex IX §2.2 evidence of CA cooperation |
Why these regulations are non-negotiable. Missing a 15-day MIR window under MDR Art. 87(3) is the single most-cited competent-authority non-conformance in EU device vigilance; persistent breach can suspend a CE certificate under MDR Art. 95. FDA Form-483 observations on late MDRs routinely cite §803.50 — late MDRs are a top-five FDA inspection finding. MDR Art. 86 PSUR missed for Class IIb/III blocks NB surveillance-audit close-out — the CE certificate cannot be sustained without PSUR acceptance.
Who uses this module and when. PRRC at every serious incident — within hours. QA / RA daily for triage and submission. QMS Manager weekly for clock-status and PSUR cycle review. NB Auditor at every surveillance audit and unannounced visit. Competent Authority during cooperative investigations.
4.2 CAPA Module
What this module is, in one paragraph. Corrective and Preventive Action (CAPA) is the QMS’s structured response to identified non-conformity or potential non-conformity. ISO 13485:2016 §8.5.2 (Corrective Action) requires the manufacturer to (a) review non-conformities including complaints, (b) determine causes, (c) evaluate the need for action, (d) plan and document action needed, (e) verify action does not adversely affect ability to meet regulatory requirements, (f) review effectiveness of action taken. §8.5.3 (Preventive Action) requires the equivalent for potential non-conformities. FDA 21 CFR 820.100 (Corrective and Preventive Action) imposes the equivalent in FDA jurisdiction with eight sub-elements — and CAPA is the most-cited FDA inspection finding across all device categories. Wrapper’s CAPA module enforces an 8-stage structured lifecycle: open → triage → under_investigation → root_cause_identified → action_plan_approved → implementation → effectiveness_verification → closed. Each CAPA carries classification (Non-Conformance / Customer Complaint / Internal Audit / Post-Market Surveillance / Management Review / Other), an action-plan narrative, and an effectiveness-verification scheduled task. The AI assistant suggests classifications and proposes training findings on CAPA escalation. The close-the-loop scheduler auto-closes the parent Issue and the associated AI impact-assessment finding once every sub-task is closed.
Regulatory pathway summary. Implements ISO 13485:2016 §8.5.2 corrective action + §8.5.3 preventive action; FDA 21 CFR 820.100 (8 sub-elements); MDR Art. 83 PMS plan + Annex III §1.1(c) post-market actions; MDSAP Chapter 4; ISO 13485 §8.2.4 (monitoring + measurement); ISO 13485 §7.5.2 (cleanliness — when CAPA touches sterility); EU AI Act Art. 9 (when CAPA triggered by AI drift).
| Purpose | The CAPA gold standard — FDA-and-ISO compliant 8-stage lifecycle. |
| What the user sees | 8-stage workflow with stage-gating; effectiveness-review task; AI classification suggestions; close-the-loop completion; per-stage SLA. |
| Regulatory frameworks | ISO 13485 §8.5.2 + §8.5.3; FDA 21 CFR 820.100 (eight sub-elements); MDR Art. 83 + Annex III §1.1(c); MDSAP Chapter 4. |
| Solves the regulatory problem of | CAPA effectiveness verification missing — the #1 FDA Form-483 observation. |
| Pathway milestone unlocked | FDA inspection §820.100 readiness; ISO 13485 §8.5 surveillance pass; MDSAP Chapter 4 evidence. |
Regulatory Specificity
Table 1 — Which regulation applies in which case
| Feature | Citation | Applies when… | Class |
|---|---|---|---|
| Review of non-conformities | ISO 13485 §8.5.2(a); 21 CFR 820.100(a)(1) | Every triggered CAPA | All classes |
| Determination of causes | ISO 13485 §8.5.2(b); 21 CFR 820.100(a)(3) | RCA stage | All classes |
| Evaluation of need for action | ISO 13485 §8.5.2(c); 21 CFR 820.100(a)(2) | Triage → action-plan transition | All classes |
| Planned and documented action | ISO 13485 §8.5.2(d); 21 CFR 820.100(a)(4) | Action-plan-approved stage | All classes |
| Verification of action | ISO 13485 §8.5.2(d) + §7.5.6; 21 CFR 820.100(a)(5) | Implementation stage | All classes |
| Effectiveness review | ISO 13485 §8.5.2(e); 21 CFR 820.100(a)(6) | Closure gate | All classes |
| Preventive action | ISO 13485 §8.5.3; 21 CFR 820.100(a)(7)-(8) | Potential non-conformity | All classes |
| CAPA classification (NC / Complaint / Audit / PMS / Mgmt Review) | ISO 13485 §8.5.2(a); FDA 21 CFR 820.100(a)(1) | Triage stage | All classes |
| Close-the-loop on AI findings | EU AI Act Art. 14 (HITL closure) | AI-originated CAPA | High-Risk AI |
Table 2 — Regulatory problem solved
| Feature | Concrete pain point |
|---|---|
| Stage-gating | CAPA closed without RCA → reopened — FDA Warning-Letter triggered. |
| Effectiveness review | Closure without effectiveness evidence — #1 FDA CAPA Form-483. |
| Classification | "Why did this complaint not become a CAPA?" — answered by classification + triage record. |
| Action-plan narrative | "Show me the documented action plan" — answered in one click. |
| Close-the-loop on linked tasks | Sub-tasks closed but parent CAPA still open — operational hygiene gap. |
Table 3 — Conformity-assessment pathway impact
| Feature | Pathway / milestone unlocked |
|---|---|
| 8-stage lifecycle | FDA §820.100 inspection readiness; ISO 13485 §8.5.2 surveillance pass |
| Effectiveness review | FDA + ISO §8.5.2(e)/(d) evidence |
| MDSAP Chapter 4 pack | MDSAP audit pass |
Why these regulations are non-negotiable. CAPA is the most-cited FDA inspection finding year on year. The 2024 FDA inspection data lists CAPA-related observations (§820.100(a)(1)-(8)) at the top of the Form-483 frequency table. Persistent CAPA gaps trigger FDA Warning Letters and Consent Decrees — both materially impair market access.
Who uses this module and when. QA Manager daily for CAPA queue. CAPA owner per stage. QMS Manager weekly for ageing review. NB / FDA at every audit.
4.3 EUDAMED Compliance Log
What this module is, in one paragraph. EUDAMED is the European database for medical devices. Six modules form the database: Actors (manufacturers, EU AR, importers, with Single Registration Number = SRN), UDI/Devices (Basic UDI-DI + UDI-DI), NB / Certificates (NB-issued conformity certificates), Vigilance (MIR + FSCA submissions), Market Surveillance (CA-only, manufacturer does not interact directly), Clinical Investigations (Sponsors). The Actors / UDI / NB-Certs / Market-Surveillance modules become mandatory 28 May 2026; Vigilance and Clinical-Investigations modules become mandatory Q3 2026. MDR Art. 31 requires Actor registration; Art. 27 + Art. 29 require UDI/Device registration; Art. 56 requires NB-certificate sync; Art. 86 requires PSUR submission for Class IIb/III via EUDAMED; Art. 32 requires SSCP (Summary of Safety and Clinical Performance) for Class III + Implants; Arts. 70–77 govern Clinical Investigations. Wrapper’s EUDAMED Log is a submission tracker covering all six modules plus a separate UK MHRA registration tab post-Brexit (UK left EUDAMED; UKRP registers with MHRA under UK MDR 2002 Reg. 7A).
Regulatory pathway summary. Supports MDR Art. 11 (EU Authorised Representative) + Art. 27 (UDI system) + Art. 29 (registration of devices) + Art. 31 (registration of manufacturers / AR / importers) + Art. 32 (SSCP) + Art. 56 (NB-certificate transmission) + Art. 70-77 (Clinical Investigations) + Art. 86 (PSUR submission); UK MDR 2002 Reg. 7A (UKRP at MHRA); Commission Notice 2025/C-…/01 (EUDAMED go-live dates).
| Purpose | Hit the 28 May 2026 + Q3 2026 EUDAMED deadlines and stay current after. |
| What the user sees | Tab-per-module dashboard plus AR/UKRP snapshot; per-submission status; mandate expiry alerts; UK MHRA tab. |
| What it replaces | EUDAMED spreadsheets and separate AR/UKRP tracking-in-a-folder. |
| Regulatory frameworks | MDR Arts. 11, 27, 29, 31, 32, 56, 70-77, 86; UK MDR 2002 Reg. 7A; Commission Notice 2025 EUDAMED dates. |
| Solves the regulatory problem of | Missing Actor SRN after 28 May 2026 → device cannot be placed on EU market; UDI mismatch at NB sync; UK RP registration drift. |
| Pathway milestone unlocked | EUDAMED Actor + UDI + NB-Cert go-live (28 May 2026); EUDAMED Vigilance go-live (Q3 2026); UKRP MHRA registration sustained. |
Regulatory Specificity
Table 1 — Which regulation applies in which case
| Feature | Citation | Applies when… | Class |
|---|---|---|---|
| Manufacturer Actor registration (SRN) | MDR Art. 31(1) | EU placement post 28 May 2026 | All classes |
| EU AR registration | MDR Art. 11 + Art. 31 | Non-EU manufacturer | All classes |
| Importer registration | MDR Art. 13 + Art. 31 | Non-EU manufacturer | All classes |
| UDI/Device registration | MDR Art. 29 + Annex VI Part C | Every device on EU market | All classes |
| NB-Certificate sync | MDR Art. 56(5) | NB-issued certificate | IIa, IIb, III, Implants |
| Vigilance Module submission | MDR Art. 87 + Art. 89 (after Q3 2026 mandate) | MIR / FSCA submission | All classes |
| SSCP submission | MDR Art. 32 | Class III + Implants | III, Implants |
| PSUR submission Class IIb/III/Implants | MDR Art. 86(2) | Annual cycle | IIb, III, Implants |
| Clinical-Investigation registration | MDR Art. 70-72 | Sponsor + investigation | All clinical investigations |
| UK Responsible Person | UK MDR 2002 Reg. 7A | UK placement | UK scope |
Table 2 — Regulatory problem solved
| Feature | Concrete pain point |
|---|---|
| Actor SRN tracker | Missing SRN after 28 May 2026 → device cannot be placed on EU market (MDR Art. 31 read with Art. 10). |
| UDI/Device sync | Device on market but UDI not in EUDAMED — Art. 29 enforcement. |
| NB-Cert sync | NB certificate issued but not in EUDAMED — Art. 56(5) gap; certificate validity in dispute. |
| Vigilance Module readiness | Q3 2026 mandate missed — vigilance submissions reverted to national portals + EUDAMED gap. |
| SSCP submission | Class III SSCP not uploaded — Art. 32 finding; public-facing summary missing. |
| UK MHRA registration | UKRP not registered with MHRA — UK device unmarketable. |
Table 3 — Conformity-assessment pathway impact
| Feature | Pathway / milestone unlocked |
|---|---|
| Full Actor + UDI + NB-Cert | EUDAMED 28 May 2026 mandate compliance |
| Vigilance Module wiring | EUDAMED Q3 2026 mandate compliance |
| SSCP submission | MDR Art. 32 evidence for Class III + Implants |
| PSUR submission | MDR Art. 86(2) NB surveillance close-out for Class IIb/III |
| UK MHRA tab | UK MDR 2002 Reg. 7A compliance |
Why these regulations are non-negotiable. Without Actor registration after 28 May 2026, the manufacturer cannot legally place a new device on the EU market. Without UDI registration after that date, the device record is invisible to regulators. Without NB-Certificate sync, the CE certificate’s status cannot be verified by the public registry. UK is structurally separate post-Brexit.
Who uses this module and when. PRRC + RA Lead daily during 2026 ramp-up. PRRC monthly thereafter. NB Auditor at EUDAMED-aware surveillance. MHRA for UK device-registration audit.
