Articles 83–89 · Annex III · US & Australia
Post-Market Surveillance Requirements for Medical Devices
The surveillance loop end to end — from the plan that starts it to the file that records what it changed.
Scope
What the course covers
Where a requirement is quoted, it is quoted in full and then explained. Where something is an interpretation rather than a rule, the course says so.
01
The regulation
Articles 83 to 89 and Annex III for the system, the plan and the reports. Annex XIV Part B for clinical follow-up. Article 32 for the summary of safety and clinical performance.
02
Beyond Europe
Vigilance reporting in the United States and in Australia, with the criteria, the deadlines and the forms — and what changed in the American inspection framework in February 2026.
03
The standards
ISO 13485 for the quality system, ISO 14971 and ISO 24971 for post-production risk management, and ISO/TR 20416 for surveillance.
Outline
10 modules, in the order the process runs
The course follows the sequence of the work rather than the numbering of the regulation, and ends where the work ends.
Introduction
What the course covers, and how it worksPMS system and PMS plan
Articles 83–86 · Annex IIIComplaint handling process
Intake, criteria, investigation, closureVigilance: criteria and timelines
Article 87 · 2, 10 and 15 daysVigilance: the report and the codes
MIR · IMDRF · US and AustraliaTrend reporting and field safety actions
Articles 88 and 89Post-market clinical follow-up
Annex XIV Part B · SSCPPSUR and PMS report
Articles 85 and 86 · the MDCG templatePost-market risk management
ISO 14971 clause 10 · ISO 24971PMS in audit and inspection
Notified body · FDA QMSR from February 2026Final test
Covering the whole courseOutcomes
What you will be able to do
01
Write a plan that survives review
Annex III as a checklist, with an action and an owner attached to every threshold.
02
Decide reportability confidently
Against the right deadline, knowing which clock started when.
03
Assemble a PSUR that supports itself
Including the denominator that turns an incident count into a rate.
04
See your file the way a reviewer will
And predict fairly accurately what they will find in it.
Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every module replayable. Transcripts are downloadable, so the content stays searchable long after the video is finished. Access does not expire, and revisions made after your purchase are included.
Audience
Who the course is for
- Quality and regulatory professionals who own this process
- The person responsible for regulatory compliance
- Anyone preparing a technical file or a certification audit
- Consultants running surveillance for several manufacturers
It assumes familiarity with medical device regulation and with a quality management system. It does not assume prior study of the articles and annexes it covers.
Certificate
Verifiable by a third party
On passing the final test, the certificate carries a verification code derived from your name and the date of completion.
An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under your quality system.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you enrol
Does it cover the IVDR as well as the MDR?
Yes. The in vitro diagnostic regulation is addressed alongside the medical device regulation wherever the requirements differ, article by article.
Does it cover markets outside Europe?
It covers vigilance reporting in the United States and in Australia, with the reportability criteria, the deadlines and the submission routes for each — and what changed in the American inspection framework in 2026.
Is the course live, or can I start whenever I want?
It is self-paced. You start when you buy it and work through it at your own speed, from any device. There are no scheduled sessions and no cohort.
How long do I have access?
Access does not expire. The course is tied to your account, and modules updated after your purchase are available to you at no additional cost.
Do I have to finish it in one sitting?
No. Progress is saved to your account, so you can stop in the middle of a module and resume where you left off.
What does the certificate confirm?
That you completed the course and passed the final test. It carries a verification code derived from your name and the date, which anyone can check on a public page. It can be filed as training evidence under your quality management system.
What happens if I do not pass a test?
You can take it again. The rules for each test are shown on screen before you start it.
Is the workbook included?
Yes. It is a gap analysis of your own documentation, arranged in the order an assessment runs, and it is designed to be worked through alongside the modules rather than read afterwards.
Can my company buy several seats?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook included with the course is a gap analysis of your own documentation, arranged in the order an assessment runs. Working through it produces a list of what is missing or partial in your file.
That list maps to the templates in the Post-Market Surveillance Kit.
Enrol
Post-Market Surveillance
10 modules, 3h 21 of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.