Risk Management Report (RMR) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN ISO 14971:2019/A11:2021 · Clause 9 · MDR Article 61
Risk Management Report (RMR) Template — EU MDR
The document that closes the risk file: residual risk acceptability, benefit-risk balance and traceability to every input, structured the way a Notified Body reads it.
The report restates the file instead of concluding it
Clause 9 asks for a conclusion: are the residual risks acceptable, and does the overall benefit-risk balance support placing the device on the market. What often gets written instead is a summary — a recap of the hazard analysis and both FMEAs with no traceable reference back to them, and no stated criterion for what “acceptable” means for this device.
A report a reviewer can act on states the criterion first, then shows the pre- and post-mitigation risk distribution against it, then references the specific inputs — HAN, dFMEA, uFMEA, post-market data — that the conclusion rests on.
None of this is difficult. It is the difference between summarising a file and closing one.
- Word .docx
- Fully editable
- README included
- Instant download
- Single document
Scope
What the template covers
Every element clause 9 requires, structured to reference the other five documents in the risk file rather than restate them.
01
Traceability to the risk file
Reference to the Risk Management Plan and traceability to every risk input: Hazard Analysis, Design FMEA, Use FMEA and post-market data.
02
Residual risk acceptability
A pre/post mitigation risk distribution table and a seven-criterion overall residual risk acceptability assessment.
03
Benefit-risk and PMS
A benefit-risk analysis structured per MDR Article 61, a post-market surveillance data review section, and the risk file change history.
Contents
What the document contains
Audience
Who the template is for
- Regulatory affairs and quality managers closing a risk file before submission
- Manufacturers whose current RMR does not reference the underlying FMEAs
- Consultants preparing the benefit-risk conclusion for a Notified Body review
The template assumes the Hazard Analysis and both FMEAs already exist, or are being built alongside it. It does not teach ISO 14971: it gives you a report already structured to clause 9, ready to complete with your own residual risk data.
What is included
What you get when you buy
- 1 Microsoft Word .docx file, fully editable
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Do I need ISO 14971 to use this?
No. The template quotes the clause it implements throughout. You will still want the standard itself for anything it references but does not reproduce.
Do I need the Hazard Analysis and FMEAs first?
You need their output to complete the report’s traceability sections. The Risk Management Documentation Kit ships all six documents built to reference each other from the start.
Is this the whole risk file?
No. This is one of six coordinated documents. It closes the file; it does not replace the Plan, the Hazard Analysis or the FMEAs.
Can I buy the full kit instead?
Yes. This template is one of six in the Risk Management Documentation Kit, priced at €349 against €414 buying all six separately.
What software do I need?
Microsoft Word, or a compatible alternative that opens .docx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full risk file?
This template is one of six in the coordinated kit.
The Risk Management Documentation Kit ships this report alongside the Risk Management Plan, Hazard Analysis and both FMEAs, all built on one shared hazard list. €349 against €414 buying the six separately.
Risk Management Report (RMR) Template — EU MDR
One Word document, the conclusion that closes the risk file.
€69.00
Related products
