EU MDR Clinical Documentation Kit
€399.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Articles 32, 61, 83-86 · Annex III · Annex XIV
EU MDR Clinical Documentation Kit
Eight templates covering the full clinical lifecycle, from the plan that sets the evaluation strategy to the periodic report that shows the benefit-risk profile still holds.
Eight documents, built at eight different times, by eight different people
The clinical lifecycle spans years: the CEP and CER get written before submission, the PMS Plan and PSUR run continuously after launch, the PMCF documents follow their own schedule, and the SSCP has to summarise all of it for Eudamed. Built independently, each document restates definitions the others already established, and the CER’s identified uncertainties never quite match what the CDP and PMCF Plan end up addressing.
A coordinated set fixes the vocabulary and cross-references once: the CDP references the CER’s gaps, the PMCF Plan references the CDP’s strategy, the PMCF Evaluation Report closes the loop back to the CER, and the PSUR reports against the PMS Plan’s own indicators.
None of this is difficult. It is the consequence of writing eight documents as eight separate projects.
- 8 Word documents
- 1 Excel master index
- Single ZIP
- Instant download
- Fully editable
- All device classes
Scope
What the kit covers
The full clinical evidence lifecycle required by MDR Articles 32, 61, 83-86 and Annexes III and XIV, cross-referenced throughout.
01
Pre-submission: plan and report
The Clinical Evaluation Plan and Report, and the Clinical Development Plan for any residual uncertainty the evaluation identifies.
02
Post-market surveillance
The PMS Plan and the Periodic Safety Update Report, reporting against the same indicators the plan defines.
03
Follow-up and publication
The PMCF Plan and Evaluation Report closing the loop back to the CER, and the SSCP for Eudamed publication on Class III and implantable devices.
Contents
What is in the ZIP
Audience
Who the kit is for
- Regulatory affairs managers assembling clinical documentation for a Notified Body submission
- Manufacturers running the clinical lifecycle across multiple device families
- Consultants who need eight documents that reference each other, not eight separate templates
- Quality managers reviewing a clinical file before submission
The kit assumes you know your device’s intended use and classification. It does not teach Articles 32, 61 or 83-86: it gives you the eight documents already cross-referenced, ready to complete with your own clinical evidence.
What is included
What you get when you buy
- 8 Microsoft Word documents, fully editable
- 1 Microsoft Excel master index
- A README with usage instructions
- Delivered as a single ZIP with an organised folder structure, instant download after purchase
- Lifetime access to future updates
Questions
Before you buy
How much do I save against buying the eight separately?
Buying the eight templates separately costs €552 (8 × €69). The kit is €399, a saving of 28%.
Do the documents actually cross-reference each other?
Yes. The CDP references the CER’s identified uncertainties, the PMCF Plan references the CDP’s strategy, the PMCF Evaluation Report closes the loop back to the CER, and the PSUR reports against the PMS Plan’s indicators.
Is this the same as the risk management file?
No. Risk management under ISO 14971 is a separate file, covered by the Risk Management Documentation Kit. The two are cross-referenced in the Risk + Clinical Documentation Bundle.
Does this cover every device class?
Yes, Class I through Class III. The SSCP applies only to Class III and implantable devices, as Article 32 requires; the other seven documents apply across all classes.
What software do I need?
Microsoft Word and Excel, or a compatible alternative that opens .docx and .xlsx files without reflowing tables.
Is this a one-off purchase?
Yes, with lifetime access to future updates at no additional cost. The licence is for single-organisation use, internal across multiple device families and projects; redistribution outside the organisation is not permitted.
Can I use this kit for an IVDR device?
No. This kit is built against MDR articles and annexes. IVDR devices need the equivalent IVDR performance evaluation and clinical documentation.
Can my company buy several licences?
Yes. Contact us before purchasing and we will arrange it under one invoice.
Need risk documentation too?
The bundle cross-references risk and clinical evidence directly.
Combine this kit with the Risk Management Documentation Kit in the Risk + Clinical Documentation Bundle and save 20%: €599 against €748 buying separately.
EU MDR Clinical Documentation Kit
Eight documents, cross-referenced, one ZIP, lifetime updates.
€399.00
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