EU MDR + EU AI Act
€999.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR 2017/745 · REGULATION (EU) 2024/1689 · EN ISO 14971
EU MDR + EU AI Act Documentation Kit
The technical documentation, risk management, clinical and post-market files of a medical device, with the EU AI Act built in, plus the AI Act procedures.
One device, one technical documentation
For a high-risk AI medical device, the Notified Body assesses the MDR and the AI Act in the same conformity assessment (Article 43(3) of the AI Act). The AI Act asks for one technical documentation (Article 11(2)), one declaration of conformity (Article 47(3)) and a post-market monitoring plan that may sit in the MDR PMS plan (Article 72(4)).
The usual result is the opposite: an MDR technical file, a separate Annex IV file, a risk file that ignores data bias and automation bias, a clinical evaluation that tests the model once and never again. The reviewer then finds the same device described twice, with different performance figures.
None of these are hard problems. They are the consequence of writing the AI Act next to the MDR files instead of inside them.
- 36 documents
- 8 AI Act procedures
- 28 templates
- Word and Excel
- Annex IV mapped to the TD
Scope
What the kit covers
The device-level files a Notified Body reviews, from technical documentation to PSUR. Every AI section is marked: sections for devices with AI functions, and sections for high-risk AI devices only. A device without AI uses the same templates and deletes them.
01
Technical documentation and risk
Annex II and III technical documentation in eight parts, with the AI Act Annex IV mapped section by section; risk management plan, hazard analysis with AI questions, FMEAs, GSPR checklist and report.
02
Clinical evidence and post-market
Clinical evaluation plan and report with MDCG 2020-1 for AI functions, clinical development plan, PMCF plan and report, SSCP, PMS plan with AI monitoring, PSUR.
03
AI Act procedures
Eight procedures for qualification, data governance, AI risk, development, conformity, changes, post-market monitoring and suppliers, with the AI templates they need.
Contents
36 documents in 12 packages
Audience
Who the kit is for
- Manufacturers preparing an MDR technical file for an AI-enabled device
- RA managers responsible for the Notified Body submission
- Clinical and PMS specialists who own the CER, PMCF and PSUR
- Risk managers extending the ISO 14971 file to AI risks
- Consultants writing technical documentation for device clients
The kit assumes your company runs a quality management system, as Article 10(9) of the MDR requires: the templates leave placeholders for your procedure IDs. It does not contain QMS procedures; for those, see the ISO 13485 + EU AI Act kit.
What is included
What you get when you buy
- 8 EU AI Act procedures and 6 AI templates in Word
- 8 technical documentation templates (Annex II and III)
- 6 risk management templates, 3 of them in Excel
- 6 clinical evaluation and PMCF templates
- PMS Plan and PSUR templates
- A README and a Master Index of all 36 documents
Questions
Before you buy
Can I use it for a device without an AI function?
Yes. The MDR templates are complete on their own. Delete the sections marked for devices with AI functions and the AI Act procedures are not needed.
How does it differ from the MDR Complete Bundle?
It contains the same technical documentation, clinical and risk management templates, with the AI Act integrated in each, plus eight AI Act procedures and six AI templates. The risk method has also been aligned into one acceptability scheme across plan, FMEAs and report.
Does it include ISO 13485 QMS procedures?
No. It covers the device files. For a complete quality management system with the AI Act built in, see the ISO 13485 + EU AI Act kit.
When do the AI Act requirements apply to medical devices?
From 2 August 2028 for high-risk AI systems covered by Annex I of the AI Act, which includes medical devices, after the amendment by Regulation (EU) 2026/1744.
Do I need a separate Annex IV file?
No. Article 11(2) asks for a single technical documentation. TD-001-04 contains a table showing where each Annex IV point sits in the TD-001 templates and the AI records.
How is AI covered in the clinical evaluation?
The CEP and CER include the three components of MDCG 2020-1: valid clinical association, technical performance and clinical performance, with performance per patient group and the effect of the AI output on users.
Which risk method do the templates use?
Risk index R = severity × probability of occurrence of harm, with three regions defined in the risk management plan. Detectability can be recorded to prioritise actions but does not change acceptability. The scales can be adapted to your device.
What format are the files?
Word for documents, Excel for the two FMEAs and the GSPR checklist. All editable, with placeholders for your company, device and document numbers.
Kit and course
The kit gives you the structure. The course explains the reasoning.
The course Artificial Intelligence in Medical Devices explains how the MDR and the AI Act apply to AI devices. The kit gives you the files in which that is documented.
EU MDR + EU AI Act Documentation Kit
36 documents in Word and Excel: technical documentation, risk, clinical and post-market templates with the EU AI Act built in, plus 8 AI Act procedures.
€999.00
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