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Medical Device Regulation (MDR) Evidence & Implementation Kit

$249.00
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Medical Device Regulation (MDR) · EU medical device compliance, made adopt-ready · Evidence & Implementation Kit
Meet the EU Medical Device Regulation (MDR), without decoding the Regulation yourself.
Every requirement handed to you as an adopt-ready control, device classification and the General Safety and Performance Requirements through clinical evaluation, UDI and EUDAMED to post-market surveillance and vigilance, with the evidence your notified body or competent authority examines.
Ready in a weekend, not a quarter.

Here is the honest situation. Regulation (EU) 2017/745, the MDR, governs medical devices placed on the EU market. It requires device classification, meeting the General Safety and Performance Requirements, risk management, clinical evaluation and post-market clinical follow-up, technical documentation, conformity assessment and CE marking, a quality management system, a person responsible for regulatory compliance, Unique Device Identification and EUDAMED registration, post-market surveillance and vigilance. A manufacturer with a legacy directive file but no MDR-grade documentation is exactly where organizations fall short.

This Kit removes the guesswork. It is the EU Medical Device Regulation (MDR) written as adopt-ready controls you personalize in a weekend, with the evidence your notified body or competent authority examines.

What you get, the moment you buy

18
Requirements as adopt-ready controls. Every requirement, written so you personalize and apply it.
18
Evidence-they-examine checklists. For each control, exactly what your notified body or competent authority examines, plus where organizations fall short, so you close the gap first.
1
Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record status, owner and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook returns your readiness as a single percentage, and exactly what to fix next.

Grounded in the EU Medical Device Regulation (MDR). Editable Word and Excel files.

The MDR raised the bar
The MDR is far more demanding than the old directive, from clinical evidence to post-market surveillance. This Kit builds its requirements into controls with the evidence a notified body asks for.

What one control looks like

This is the opening control, where the program begins. All 18 are built to this depth.

MDR-1 Confirm device status and economic operator role SCOPE
Put this control in place

Determine and document whether [your organization name]'s products are medical devices under the MDR and its role as manufacturer, authorised representative, importer or distributor, so the applicable obligations are clear and the organization can evidence its determination.

Regulation note.

Regulation (EU) 2017/745 (the MDR) assigns different obligations to manufacturers, authorised representatives, importers and distributors of medical devices.

Evidence your notified body or competent authority examines
  • A device qualification determination
  • Economic operator role identified
  • Records of the determination
Common finding they raise: Device status and the economic operator role are not determined.

Why this is not another template pack

  • The evidence is the point. A requirement you cannot evidence is a gap waiting to be found. This tells you what your notified body or competent authority examines and where organizations fall short, for every requirement.
  • The specifics built in. The regulation's distinctive requirements are written into the controls, not left generic.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. This work shares its shape with related security and safety frameworks, so it feeds your wider program.

Who buys this

Medical device manufacturers, authorised representatives, importers and distributors and their regulatory, quality and clinical teams. Whether it is a first CE route or a compliance uplift, you save weeks and walk in with your classification, GSPRs, technical documentation and post-market surveillance structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 18 requirements
✓  A completed control matrix
✓  The evidence your notified body or competent authority examines
✓  Your core controls in place
✓  A readiness percentage and a fix list
✓  The highest-risk gaps closed

Common questions

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

Does our old CE file still cover us? No. The MDR requires MDR-grade technical documentation, clinical evaluation and post-market surveillance. This Kit covers the specifics.

Does it cover UDI and EUDAMED? Yes. Unique Device Identification and EUDAMED registration are built as controls.

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

Do not face your notified body or competent authority with requirements you cannot show.
Every requirement is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be 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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