MedTech Post-Market Compliance

Handle every complaint, from first email to MHRA report

Complaint intake, report preparation, corrective actions and trend review in one case record.

UK MDR Part 4A, in force since 16 June 2025 Devices, IVDs and active implantables GB, NI and EU rules on one case

Post-market surveillance hub on DeX

Audit trail on Example data

Case inbox

See everything open

Case	Device	Severity	Clock	Owner	Status
PMS-0418Occlusion alarm not triggered	Infusion pump IP-200Lot 24-117	High	01d 06h	JPJ. Patel	Report drafting
PMS-0421Display flicker reported by distributor	Patient monitor PM-5Lot 25-031	Medium	Not started	AKA. Khan	Triage
PMS-0415Unexpected result, repeat test differs	IVD analyser QX-1Reagent lot R-882	High	04d 19h	SRS. Reid	Investigating
PMS-0422Packaging seal complaint, portal	Infusion set IS-12Lot 25-204	Low	Not started	AIAgent	Intake
PMS-0409Service record: battery fault	Patient monitor PM-5Lot 24-990	Medium	09d 02h	JPJ. Patel	Follow-up

Select a case to open its record. Devices, lots, people and timers are illustrative.

Source message · distributor email

Customer site reports the IP-200 pump did not raise an occlusion alarm during infusion. Line was found kinked by nursing staff. Patient monitored, no injury. Unit serial 7741-A from lot 24-117 is quarantined for return.

Extracted fields

DeviceInfusion pump IP-200

Model / lotIP-200 · 24-117

EventAlarm failure, occlusion

Patient outcomeNo injury reported

Timeline

Email received and case created09:12
Device, model and lot matched09:13
Duplicate check: 1 linked case09:13
Reportability proposal awaiting sign-off09:20

Linked cases

PMS-0392 · Same lot, alarm delayClosed

AI proposal · PMS-0418Awaiting sign-off

Proposed: reportable serious incident

Alarm failure on a device whose alarm is a risk control. A recurrence could lead to serious deterioration in health. Criteria from the manufacturer's PMS procedure are cited below.

Review pending. Reporting deadlines run from manufacturer awareness, not reviewer confirmation.

Criteria checklist

An incident occurred involving the device
The device is suspected to be a contributory cause
?Outcome could have led to serious deterioration in health
Similar event found in linked case PMS-0392

The lead confirms or overrides. Each decision is stored with its rationale.

MHRA vigilance report · PMS-0418Pre-filled 86%

Manufacturer and device detailsComplete

Event description and outcomeComplete

Distribution of affected lotMissing field

Initial root cause assessmentNeeds input

Review and approvePending

Missing-field prompt

Agent: Units shipped from lot 24-117 by market are needed. Request sent to Supply Chain; reminder set before the clock threshold.

Submission log

draft v1 generated 09:41
RA review requested · J. Patel
● awaiting approval
follow-up report scheduled

Open 2

CAPA-071 · Alarm threshold review

SRS. ReidDue 28 Oct

CAPA-073 · Seal supplier audit

AKA. KhanDue 04 Nov

Investigate 1

CAPA-069 · Lot 24-117 root cause

FSCA linkedDue 21 Oct

Implement 1

CAPA-064 · Firmware alarm fix

JPJ. PatelDue 30 Oct

Effectiveness check 1

CAPA-058 · Battery supplier change

EffectiveClosed

Actions by stage, owner, due date and effectiveness check. Customer notifications are tracked with each FSCA.

Complaint rate by lot · Infusion pump IP-200per 1,000 units

Within thresholdAbove thresholdAlert threshold

Open signals

IP-200 lot 24-117 · alarm failuresReview

PM-5 · battery faults, GB marketWatching

Slice by

LotDeviceFailure modeMarket

PMSR · Infusion pump family

1. Device description and scopeApproved

2. Complaint and incident summaryApproved

3. Trend analysisIn review

4. CAPA and FSCA summaryDrafted

5. Conclusions and actionsDrafted

Data sources

Case recordsCAPA boardSignalsSales volumes

Reviewer comments

S. Reid: Add the lot 24-117 signal to section 3 with the threshold used.

Why it's harder now

Stricter rules, same old spreadsheets

GB post-market duties got stricter in 2025. Most small manufacturers still run them on spreadsheets and inboxes.

16 June 2025GB post-market surveillance rules in force

Part 4ANew duties added to the UK MDR 2002

2 to 5 peopleTypical RA/QA team carrying the extra load

TodayWith DeX

IntakeComplaints arrive by email, phone, portal and distributor, then get re-keyed.Every channel lands in one structured case.

ReportabilityOne or two experts decide. The reasoning is rarely written down the same way.AI proposes with cited criteria. A lead signs off.

DeadlinesReporting clocks live in calendars and inboxes.A timer on every case, escalating before breach.

Periodic reportsPMSRs stitched together by hand each cycle.Drafted from live data in MHRA's PMSR format.

GB, NI and EUSimilar but different duties, tracked in parallel.Separate rule sets applied to the same case.

Feedback loopFindings rarely reach risk, CAPA or design.Findings update the risk file and feed design change.

Team loadA small team can't absorb the extra volume.Agents do the reading, drafting and chasing.

What DeX does

Working records and reviewer responsibilities

A post-market surveillance hub built on DeX, set up around your PMS plan and running in your cloud.

DeX agents

Reading, drafting and chasing

Every report is read, coded and matched to device and lot. Drafts and reminders go out automatically.

Your RA and QA leads

Decide every report, risk and submission

Each decision is logged with its rationale.

Intake

Assess

Report

Correct

Trend

Periodic report

One complaint, start to finish

Follow one complaint from inbox to inspection-ready

Here's what happens to a single complaint. Hover over it to pause.

PMS-0418

IntakeAny channel

Complaint arrives

Case PMS-0418Infusion pump IP-200 · Lot 24-117

Example case

Status

With

Report clock

What's included

Tools for post-market teams

Capture

Multi-channel intake

Email, web form, distributor upload and API into one case.

AI case structuring

Pulls device, event, outcome and coding terms from free text.

Decide

Reportability support

A proposed decision with reasoning, for human sign-off.

Deadline clock

A statutory timer per case. Escalates before breach.

Report

Report drafting

Pre-filled vigilance and periodic reports in the current format.

GB and EU rule sets

Separate obligations, applied to the same case.

Act

CAPA and FSCA tracking

Owners, effectiveness checks and customer notices.

Trends and signals

Dashboards by device, lot, failure mode and market.

Govern

Audit trail

Role-based access, approvals and full change history.

Knowledge base

PMS plan, SOPs and past decisions, searchable.

Who it's for

Built for lean RA and QA teams

Daily users

Regulatory affairsQuality assuranceComplaints handlersVigilance leads

Contributors

Customer serviceField serviceDistributorsClinical affairs

Decision makers

Head of RA/QAPerson responsible for regulatory complianceCOO

Reads the output

UK Responsible PersonsMHRAApproved body auditors

Best fit

Companies selling devices into GB

UK device and IVD makers, 20 to 500 staff

Overseas manufacturers selling into GB

UK Responsible Person service providers

Importers and distributors