ipp. academy
Article 15 has entered the chat.
Somebody said ‘compliance’ three times — and now the PRRC is here. No, they are not your emergency alarm.
The role the MDR holds personally responsible — and how not to summon it in a panic.
Somebody said ‘compliance’ three times.
Now the PRRC is here.
Usually mid-crisis. Usually expected to make a problem vanish. A Notified Body emails, an incident lands, and someone remembers there's supposed to be a Person Responsible for Regulatory Compliance. But Article 15 didn't create a fire extinguisher — it created a role with duties that run continuously: checks before release, technical documentation and the Declaration of Conformity kept current, post-market surveillance, and vigilance. A role you only wake in an emergency is a role already behind.
The PRRC owns the connective tissue.
Article 15 puts on the PRRC
- ✓conformity is checked before devices are released
- ✓technical documentation & DoC are kept up to date
- ✓post-market surveillance obligations are met
- ✓vigilance reporting (incidents, FSCA, trends) happens on time
The PRRC does not own alone
- –fixing every root cause — action owners do the work
- –being the company's 24/7 emergency line
- –guaranteeing compliance with no authority or time
- –the business call to recall — but ensures the process runs
A name on an org chart is not a role.
- ✗A PRRC appointed on paper — no authority, no time, no budget
- ✗The founder self-appoints at 11 p.m., minus the Article 15 qualification
- ✗Vigilance policy: ‘we'll report it if someone asks’
- ✗PMS is a folder nobody opens; the PSUR is written the night before
- ✗The PRRC is only summoned once something is already on fire
PRRC-in-a-Box™
Just add a name!* Instantly satisfies Article 15 — on paper, in the wrong font, with no authority whatsoever.
Give the role a mandate, and the clock a keeper.
A real appointment
Name, qualification, authority and time — in writing. Small company? An external PRRC works, if permanently and continuously available.
PRRC role training →Living docs, checked
Conformity confirmed before release; technical documentation and the Declaration of Conformity kept current — not reconstructed later.
Evidence & Tech Doc →The engine that runs
PMS plan → PMS report / PSUR on schedule; vigilance decision logic and timelines; complaints feed CAPA; FSCA ready before you need it.
QMSaaS →Post-market is where the PRRC lives.
The role touches Build (docs before release) but its home is the post-market reality of Operate & Scale.
- Intended use & class
- Applicable obligations
- Light · Essential · Certified
- PMS plan & indicators
- Vigilance decision logic
- PRRC mandate & roles
- Tech doc kept current
- Declaration of Conformity
- Conformity checked pre-release
- PSUR & PMS due dates
- Draft vigilance assessments
- The decision stays human
- PMS reports & PSUR
- Vigilance & FSCA
- Complaints → CAPA
Vigilance has clocks. The PRRC's job is to start them on time — not to discover them when they've already run out.
Walk the full Journey →The PRRC shelf — proof, tools and the source map.
Three moves before your next audit.
Put the PRRC's name and authority in writing
A title with no mandate, time or qualification is a finding waiting to happen. Fix the paperwork and the power behind it.
Write the vigilance decision rule now
When is something reportable, and in what timeline? Decide the logic in calm, so the clock never starts in a panic.
Schedule the PMS report / PSUR like a deadline
Post-market evidence is a cadence, not a someday. A date on the calendar beats a good intention every time.
No. 06 · PRRC Edition · 2026
Be a role, not an alarm.
The full PMS, vigilance and complaint processes, the PRRC mandate and the role training live in the Makerspace and on ipp-nbg.de. Bring your appointment letter — we'll help you make it mean something.
academy.easy13485.com
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Mon–Fri · 8:00–14:00 · NürnbergField Guide No. 06 · 2026
A recurring series. Next: Clinical.