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EU IVDR In Vitro Diagnostic Regulation Evidence & Implementation Kit

$249.00
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EU IVDR · In Vitro Diagnostic Regulation 2017/746 · Evidence & Implementation Kit
Place IVDs on the EU market under the IVDR, without turning the Regulation into controls yourself.
Every IVDR obligation handed to you as an adopt-ready control, from classification and the general safety and performance requirements through the QMS, technical documentation and performance 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 In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 reclassified most IVDs into classes A to D and pulled the vast majority into notified body oversight. It requires a QMS aligned with ISO 13485, a person responsible for regulatory compliance, technical documentation, a performance evaluation with scientific validity and analytical and clinical performance, conformity assessment by class, UDI and Basic UDI-DI, registration in EUDAMED, and post-market surveillance with PSURs, PMPF and vigilance. Building that dossier and evidencing it to a notified body is a major program, and a device with a weak performance evaluation or missing PMS is exactly where IVD manufacturers fall short.

This Kit removes that build. It is every IVDR 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

37
Obligations as adopt-ready controls. Every IVDR obligation, from classification and the safety and performance requirements through the QMS, technical documentation, performance evaluation, UDI, EUDAMED and post-market surveillance, written so you personalize and apply it.
37
Evidence-they-examine checklists. For each control, exactly what a notified body examines, plus where IVD manufacturers fall short, so you close the gap first.
1
IVDR 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 In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, with the Annex VIII classification, the Annex I safety and performance requirements, the QMS and person responsible for regulatory compliance, the Annex XIII performance evaluation, UDI, EUDAMED and post-market surveillance called out. Editable Word and Excel files.

Performance evaluation is where the dossier is won or lost
The IVDR requires a performance evaluation demonstrating scientific validity, analytical performance and clinical performance, documented in a performance evaluation report a notified body scrutinises hardest. A thin evaluation sinks the conformity assessment. This Kit builds the performance evaluation 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 IVDR compliance begins. All 37 are built to this depth.

IVDR-1 Assign risk class per Annex VIII CLASSIFICATION
Put this control in place

Apply the seven implementing rules of Annex VIII to determine whether [your device name] falls into class A, B, C or D, considering intended purpose, the condition detected, whether results are decisive, patient management impact, and any self-testing or near-patient use, then record the rule number and reasoning that led to the chosen class in a signed classification rationale.

Regulatory note.

Where several rules apply, the rule resulting in the higher classification governs the device.

Evidence a notified body examines
  • Classification rationale document citing the applied Annex VIII rule
  • Intended purpose statement approved by regulatory
  • Decision log showing rules considered and rejected
  • Sign-off record from the person responsible for regulatory compliance
Common finding they raise: Manufacturers often default to a lower class without documenting why the higher rules do not apply.

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.
  • Performance evaluation and EUDAMED built in. The performance evaluation, the QMS, UDI, EUDAMED registration and post-market surveillance are written into the controls, the deliverables the IVDR requires.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. The IVDR QMS aligns with ISO 13485 and connects to the MDR, so this work feeds your wider medical device quality program.

Who buys this

IVD manufacturers, authorised representatives, importers and distributors placing in vitro diagnostics on the EU market, and the regulatory, quality and clinical leads who own IVDR. Whether it is a first CE application or a class 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 37 obligations
✓  A completed IVDR control matrix
✓  The evidence a notified body examines
✓  Your classification and performance 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 performance evaluation? Yes. Scientific validity, analytical and clinical performance and the performance evaluation report 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 performance evaluation.
Every IVDR 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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