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EU MDR Medical Devices Regulation Evidence & Implementation Kit

$249.00
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EU MDR · Medical Devices Regulation 2017/745 · Evidence & Implementation Kit
Place medical devices on the EU market under the MDR, without turning the Regulation into controls yourself.
Every MDR obligation handed to you as an adopt-ready control, from classification and the general safety and performance requirements through the QMS, technical documentation and clinical evaluation to UDI, EUDAMED and post-market surveillance, with the evidence a notified body examines.
Conformity-ready in a weekend, not a quarter.

Here is the honest situation. The Medical Devices Regulation (EU) 2017/745 raised the bar for every device on the EU market: stricter classification including Rule 11 for software, a QMS aligned with ISO 13485, a person responsible for regulatory compliance, deeper technical documentation, clinical evaluation with a robust clinical evaluation report, UDI and the Basic UDI-DI, registration in EUDAMED, and reinforced post-market surveillance with PSURs, PMCF and vigilance. Building that dossier and evidencing it to a notified body is a major program, and a device with a weak clinical evaluation or missing post-market surveillance is exactly where device manufacturers fall short.

This Kit removes that build. It is every MDR obligation written as an adopt-ready control you personalize in a weekend, with the evidence a notified body examines.

What you get, the moment you buy

38
Obligations as adopt-ready controls. Every MDR obligation, from classification and the safety and performance requirements through the QMS, technical documentation, clinical evaluation, UDI, EUDAMED and post-market surveillance, written so you personalize and apply it.
38
Evidence-they-examine checklists. For each control, exactly what a notified body examines, plus where device manufacturers fall short, so you close the gap first.
1
MDR Control Matrix, pre-built. Every obligation in a working spreadsheet, ready to record status, owner and evidence location across your devices.
1
Gap & Readiness Assessment. Score each obligation and the workbook returns your readiness as a single percentage, and exactly what to fix next.

Grounded in the Medical Devices Regulation (EU) 2017/745, with the Annex VIII classification, the Annex I safety and performance requirements, the QMS and person responsible for regulatory compliance, the clinical evaluation, UDI, EUDAMED and post-market surveillance called out. Editable Word and Excel files.

Clinical evaluation is where the dossier is won or lost
The MDR requires a clinical evaluation demonstrating the device's safety and performance, documented in a clinical evaluation report a notified body scrutinises hardest, backed by post-market clinical follow-up. A thin evaluation sinks the conformity assessment. This Kit builds the clinical evaluation and PMCF controls and the evidence, so the part the notified body examines most is solid.

What one control looks like

This is classification under Annex VIII and the general safety and performance requirements, where MDR compliance begins. All 38 are built to this depth.

MDR-1 Determine device class under Annex VIII CLASSIFICATION
Put this control in place

Apply the classification rules set out in Annex VIII to assign [your device name] to class I, IIa, IIb, or III, documenting the intended purpose, duration of contact, invasiveness, active or non-active nature, and every rule considered, and record the reasoning and outcome in a signed classification rationale retained within the technical documentation.

Regulatory note.

Where several rules apply, Annex VIII requires the highest resulting class to be assigned.

Evidence a notified body examines
  • Signed classification rationale referencing each applicable Annex VIII rule
  • Statement of intended purpose and intended user population
  • Duration and invasiveness assessment worksheet
  • Record of higher-class outcome applied where two rules conflict
Common finding they raise: Manufacturers apply a single obvious rule and overlook implementing, measuring, or software-specific rules that raise the class.

Why this is not another template pack

  • The evidence is the point. A requirement you cannot evidence fails the conformity assessment. This tells you what a notified body examines and where manufacturers fall short, for every obligation.
  • Clinical evaluation and EUDAMED built in. The clinical evaluation, the QMS, UDI, EUDAMED registration and post-market surveillance are written into the controls, the deliverables the MDR requires.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. The MDR QMS aligns with ISO 13485 and connects to the IVDR, so this work feeds your wider medical device quality program.

Who buys this

Medical device manufacturers, authorised representatives, importers and distributors placing devices on the EU market, and the regulatory, quality and clinical leads who own MDR. Whether it is a first CE application or an MDR transition, you save weeks and walk in with classification, the dossier and evidence structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 38 obligations
✓  A completed MDR control matrix
✓  The evidence a notified body examines
✓  Your classification and clinical evaluation anchored
✓  A readiness percentage and a fix list
✓  The common conformity failures designed out

Common questions

Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.

Is this legal advice? No. It is an implementation toolkit grounded in the Regulation. For a specific matter consult your notified body or counsel; this gets your controls and evidence in order fast.

Does it cover clinical evaluation? Yes. The clinical evaluation, the CER and post-market clinical follow-up are their own control group, because notified bodies scrutinise them hardest.

Does it cover EUDAMED and UDI? Yes. UDI, the Basic UDI-DI and EUDAMED actor and device registration are built as controls.

What if it is not for me? A 30-day money-back guarantee.

Do not submit a dossier with a thin clinical evaluation.
Every MDR obligation is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be conformity-ready this weekend.

Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com

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