EU AI Act Medical Device Kit
€299.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
REGULATION (EU) 2024/1689 · REGULATION (EU) 2026/1744 · EU MDR 2017/745
EU AI Act Medical Device Kit
Eight procedures and eight templates that add the EU AI Act to the ISO 13485 quality management system you already run.
Most AI device manufacturers try to build a second quality system
An AI function inside a Class IIa, IIb or III device usually makes the device a high-risk AI system under Article 6(1) of the AI Act. The obligations of Articles 9 to 17 then apply on top of the MDR. The common reaction is to write a separate AI management system, with its own manual, its own risk file and its own technical documentation. Notified Bodies then find two files describing the same device, and the two rarely agree.
The AI Act does not ask for that. Article 17(3) lets a manufacturer with an MDR quality system add the AI requirements to it, Article 11(2) asks for a single technical documentation, and Article 47(3) for a single declaration of conformity. What is missing in most ISO 13485 systems is narrower: data governance for training and test data, a model card, AI-specific risks, post-market monitoring of model performance, and the agreements with suppliers of AI components.
None of these are hard problems. They are the consequence of reading the AI Act as a list of articles rather than as a set of records you have to be able to produce for each device.
- 8 procedures
- 8 templates
- 16 documents in Word
- One procedure per process
- Aligned with Regulation (EU) 2026/1744
Scope
What the kit covers
The kit supplements an existing ISO 13485 quality management system. It does not replace any of your procedures: each SOP has a table where you write the ID of the QMS procedure it connects to.
01
Qualification and QMS integration
Whether the device contains an AI system, whether it is high-risk under Article 6(1), which obligations apply, and where each Article 17 element sits in your QMS.
02
Development of the AI function
Data governance (Article 10), AI risk management (Article 9), design, verification and validation, the model card and the information for users (Articles 13 to 15).
03
Conformity and life cycle
Technical documentation and declaration of conformity, substantial modifications, post-market monitoring and incidents (Articles 72 and 73), suppliers and general-purpose AI models.
Contents
16 documents, one procedure per process
Audience
Who the kit is for
- QA/RA managers of manufacturers of AI-enabled devices
- PRRCs who must cover the AI Act in the existing QMS
- Software and data science leads who own the model
- Start-ups preparing the first Notified Body submission of an AI device
- Consultants who implement the AI Act for device clients
The kit assumes an ISO 13485 quality management system is in place, with procedures for design control, risk management, change control, post-market surveillance and supplier management. If you have none of these yet, the ISO 13485 + EU AI Act kit is the right starting point.
What is included
What you get when you buy
- 8 standard operating procedures in Word
- 8 templates in Word
- A README with the order in which to apply the kit
- A Master Index of all documents and their links to the AI Act
- Article references aligned with Regulation (EU) 2026/1744
- Placeholders for your company name and QMS procedure IDs
Questions
Before you buy
Is my device a high-risk AI system?
If it contains an AI system that is the device or a safety component of it, and the device needs a Notified Body under the MDR, it is high-risk under Article 6(1). Template F-AI-01.1 walks through the decision and records it. If the answer is no, only AI literacy and, where relevant, the transparency duties of Article 50 apply.
When do the high-risk requirements apply to medical devices?
From 2 August 2028 for AI systems covered by Annex I of the AI Act, which includes medical devices, after the amendment by Regulation (EU) 2026/1744. A device in development today will be assessed against them, so the records are best built during development, not after it.
Do I need a separate quality management system for the AI Act?
No. Article 17(3) allows the AI requirements to be part of the quality system you keep under the MDR. The kit is built that way: eight procedures that plug into your existing SOPs, mapped in F-AI-01.2.
Do I need EN 18286 or ISO/IEC 42001?
No. The kit is written against the text of the AI Act. EN 18286 is cited where it helps, but you do not need to buy it to use the procedures. ISO/IEC 42001 is not required for the AI Act.
Does the kit include the MDR technical documentation?
No. It contains the AI records that go into it (model card, datasheets, Annex IV index). If you also need the MDR technical documentation, clinical evaluation and risk management templates, choose the EU MDR + EU AI Act kit.
How does it differ from the ISO 13485 + EU AI Act kit?
This kit adds the AI Act to a QMS you already have. The ISO 13485 + EU AI Act kit is a complete quality management system with the AI Act built into its procedures.
Is the Notified Body going to accept these documents as they are?
They are templates. You fill them with your device, your data and your decisions, and the Notified Body assesses the result. The structure follows the articles the Notified Body checks under Article 43(3).
What format are the files?
Word documents, editable, with your company name and procedure IDs as placeholders. No macros and no software to install.
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, module by module. The kit gives you the procedures and records to put that into practice.
EU AI Act Medical Device Kit
8 procedures and 8 templates in Word that add the EU AI Act to your ISO 13485 quality management system.
€299.00
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