The situation
The device is on the market and the obligations are now continuous. A PSUR is due and the data for it lives in five places. A complaint arrived that someone thinks might be reportable and nobody is sure in which market, by when. A notified body has asked how the PMS plan feeds the clinical evaluation. A distributor in India has mentioned the Materiovigilance Programme and nobody in head office has heard of it.
What goes wrong when this is handled late
Post-market systems built after the certificate fail in predictable ways. Complaints are categorised by the complaint handler's words rather than by the hazard list, so trends are invisible. The PSUR is written from memory, without exposure data, and reads as an assurance rather than an analysis. Vigilance decisions are made case by case without a recorded method, so the one that goes wrong cannot be defended. PMCF is a plan on paper with no data behind it when the clinical evaluation comes up for renewal. And a signal that should have changed the risk file never reaches it, because the two systems were never connected.
What Authentcare does
Assess. Review the PMS system against MDR Chapter VII and Annex III, IVDR Chapter VII, the FDA's Part 803 and 806 requirements, the QMSR and ISO 13485 clause 8, and India's Materiovigilance Programme as your markets require. Check that the PMS plan is proportionate to class and risk, that complaint categories map to hazards, that the vigilance decision method is written and that the PSUR calendar is right.
Develop. Build the PMS system and plan; the complaint-handling procedure and categorisation; the vigilance procedure with its market annexes; the trend-reporting method and thresholds; the PMCF or PMPF plan integrated with the clinical or performance evaluation; and the CAPA linkage so that post-market findings re-enter the risk file and the design. Prepare the PMS report or PSUR from the system's data, on the cadence the class requires.
Coordinate. Support each vigilance decision and report, in the manufacturer's name, within the timelines. Prepare the PSUR for the notified body's review. Keep the EUDAMED position under review: the Actor, UDI/Device, Notified Bodies and Certificates and Market Surveillance modules have been mandatory since 28 May 2026, while vigilance continues through national routes until the Vigilance module is mandated.
Which report your device needs
| Device | Report | Cadence | Basis |
|---|---|---|---|
| MDR Class I | PMS report | Updated when necessary; available on request | MDR Article 85 |
| MDR Class IIa | PSUR | At least every two years | MDR Article 86 |
| MDR Class IIb and III | PSUR | At least annually; IIb implantable and III submitted to the notified body | MDR Article 86 |
| IVDR Class A and B | PMS report | Updated when necessary; available on request | IVDR Article 80 |
| IVDR Class C and D | PSUR | At least annually | IVDR Article 81 |
| Any device in the US | Medical device reports and corrections and removals as events require | Event-driven, within statutory timelines | 21 CFR 803 and 806 |
| Any device in India | Adverse event reports under the Materiovigilance Programme | Event-driven | Medical Devices Rules 2017 |
What you receive
- PMS system and PMS plan to MDR Article 84 and Annex III, or IVDR Article 79, proportionate to class and risk
- PMS report (MDR Article 85, Class I) or PSUR (MDR Article 86, Class IIa, IIb and III; IVDR Article 81), prepared on the cadence the class requires, following MDCG 2022-21
- PMCF plan and evaluation report, or PMPF plan and report for IVDs, integrated with the clinical or performance evaluation
- Complaint-handling procedure and complaint categorisation built from the hazard list
- Vigilance procedures — serious incident reporting, field safety corrective actions and field safety notices — with the timelines per market and the MDCG 2023-3 terminology
- Trend reporting method and thresholds under MDR Article 88
- FDA medical device reporting (21 CFR 803) and corrections and removals (21 CFR 806) procedures
- Materiovigilance Programme of India reporting procedure under the Medical Devices Rules 2017
- CAPA linkage so that post-market signals re-enter the risk file and the design
Frameworks and editions
Applicability is device-specific. Which of these apply, and in what combination, depends on device type, intended purpose, classification and target market; the applicability assessment at the start of every engagement settles it in writing.
| Reference | Edition or version cited | Where it applies |
|---|---|---|
| EU MDR 2017/745 Chapter VII and Annex III; IVDR 2017/746 Chapter VII | As amended | PMS, PSUR, vigilance, trend reporting and market surveillance |
| MDCG 2022-21 | Current revision | PSUR content and format |
| MDCG 2023-3 | Current revision | Vigilance terms and concepts |
| 21 CFR Part 803 and Part 806 | Current CFR | FDA medical device reporting; reports of corrections and removals |
| FDA QMSR, 21 CFR Part 820; ISO 13485:2016 clause 8 | In force since 2 February 2026; third edition with Amendment 1:2024 | Complaint files, feedback, CAPA |
| India Medical Devices Rules 2017; Materiovigilance Programme of India | As amended; current MvPI guidance | Adverse event reporting and post-approval obligations in India |
| Commission Decision (EU) 2025/2371 | EUDAMED Actor, UDI/Device, NB and Certificates, Market Surveillance modules mandatory since 28 May 2026; Vigilance module not yet mandatory | Vigilance continues through national routes until the module is mandated |
What this engagement excludes
- Making vigilance reports in the manufacturer's name; the manufacturer or its authorised representative submits, Authentcare prepares
- Clinical or performance study execution for PMCF or PMPF
- Complaint intake operations; the system is designed, the manufacturer runs it
- Regulator fees
Boundary
Reporting obligations and timelines belong to the manufacturer; Authentcare builds the system and supports each report.