Regulatory & Quality SpecialistEU MDR
Branch · The CE file
CE marking under the EU MDR: the technical file, clinical evaluation and the notified body.
For: Device manufacturers, authorised representatives, importers and distributors serving the EU; hospital teams using the health institution exemption
Before you start: The Regulatory & Quality Specialist core track, or its baseline check at Medium or above
The arc · 6 weeks · The CE file
What you'll be able to do
The story
Halcyon Medical seeks CE marking for the needle-dislodgement monitor, a 14-day ECG patch and a needle-free injector, while its distribution side handles field notices for hospitals in the network. You work the EU file with Nadia Al-Khatib.
“The MDR class is the highest one any applicable rule gives. Walk every rule; write why each applies or not.”
Inside the track
The real screens: My track, a step with your mentor, a simulation, your skills map and the certificate.
The arc
Each week is one working shift: learn, see inside, do, work, think, check, reflect. Open a week to see its real steps.
Gate by gate
Three products, three classification rationales for the notified body.
You make: MDR classification rationales for three products
Forty unexplained 'N/A's, and a hospital that wants to make its own device.
You make: GSPR checklist and technical documentation map
A notified body audit in March and an identification system to finish first.
You make: Mock notified body audit record
A clinical evaluation that cannot lean on someone else's device, and a claim that would raise a class.
You make: Clinical evaluation plan
Two notices, a lookback of forty-one patients, and a PMS plan due Friday.
You make: Post-market surveillance plan
The notified body receives your file.
You make: Capstone presentation and sign-off
Proof
A step is done when there is evidence: a simulation score, a saved work document, a passed check or a signed observation. Opening a page never ticks anything.
The certificate
It names the track and the level you completed. Your portfolio holds the work behind it.
For one device, the classification rationale, GSPR evidence map, technical documentation outline and clinical evaluation plan.
Evidence it gives: The core a notified body reviews.
Audit one technical file and the QMS processes behind it as a notified body would, then close the findings with evidence.
Evidence it gives: Self-audit evidence before certification.
A PMS plan for one device, with one real or simulated vigilance case run through it to closure.
Evidence it gives: A PMS record of the kind notified bodies sample.
Three levels
A baseline check on day one places you, or you choose. The competencies are the same at every level; the support and the pressure change.
Baseline under 50%, or chosen · simulations at Foundation
Worked examples first; Foundation simulations with the coach; the extra cases hidden.
Baseline 50% to 74%, or chosen · simulations at Practitioner
Practitioner difficulty; the injector, wound therapy and home apnoea cases shown.
Baseline 75% and above, or chosen · simulations at Expert
Expert difficulty, every case, timed boss week.
Ways to get this track
Deep Dive
$199for 12 months
General Essentia, the Studios and Design are not included. Subscribe within 30 days and what you paid counts toward your plan.
Premium · Pro
$299a year with Premium
Organisation licence
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FAQ
Anything else, write to the team and we answer directly.
Yes. An organisation's licence includes every track, core and branch, with the Platform, Medical City, Essentia, the App and the dashboard. Your organisation enrols you on the track, and it appears under My track; there is nothing extra to buy.