Instructions for Use for Application Managers

1. GENERAL INFORMATION

Product name:	The Minddistrict Platform
Manufacturer:	Minddistrict Development B.V. Jan Evertsenstraat 749 1061 XZ Amsterdam Email: info@minddistrict.com Website: Digital mental health platform for healthcare providers Support page: Support
UDI:	(01)8720892566928(8012)32.13.2
Version:	32.xx.xxx
Date of issue:	October 2nd, 2026
Medical product:	Medical Device Directive: This stand-alone software is a Class I medical device according to Rule 12 of the EU Directive 93/42/EEC.
CE-marking:	Medical Device Regulation transition: The Minddistrict Platform is currently in transition towards stand-alone software which is a medical device of risk class IIa according to Rule 11 of Annex 8 (6) of the Regulation (EU) 2017/745.

1.1. Feedback and incidents

This Instructions for Use is intended for the correct application of the Minddistrict Platform.

Please read this information carefully and follow the instructions contained therein. Any questions can be answered on the Minddistrict Platform support page or emailed to info@minddistrict.com.

[!WARNING] Any serious incident or feedback that has occurred in relation to the Minddistrict Platform should be reported to the manufacturer at compliance@minddistrict.com and to the competent authority of the Member State in which the user and/or patient is established. Other feedback can be sent to the same address.

1.2. Language

This Instructions for Use is available in the following languages:

English
Dutch - link
German - link

1.3. Paper version

Paper versions of the Instructions for Use are available on request at no additional cost. To obtain a paper version, please send an e-mail to our compliance department compliance@minddistrict.com, and your request will be processed within 7 calendar days.

2. INTENDED USERS

The Application Manager is a role within the healthcare organisation responsible for configuring the Minddistrict Platform and creating professional accounts. The Application Manager receives implementation training from Minddistrict, which includes face-to-face training, e-learning modules and detailed documentation on how to perform the job effectively. In addition to that, the Minddistrict website contains extensive documentation which describes the roles available and functions.

The table below provides an overview of the roles that the Application Manager can assign. Please note that a therapist may take on more than one role if needed.

Available role	Main action
Application Manager	Configures the Minddistrict Platform and creates professional accounts.
Auditor	Could access data reports such as NEN 7513 logging reports.
Connected Therapist	Adds patients to their caseload for the purposes of administering treatment using the Minddistrict Platform, mostly in a blended care setting.
Data Analyst	Sees, or processes, data without personal identifiable information.
Data Officer	Configures data collection and initiate data exports.
Secretary	Processes new patient registrations, links new patients to the therapist, prepares tools for them and activates or deactivates accounts.
Supervisor	Supervises therapists. Has 'read only' access to the files of patients being treated by the connected therapists that he or she supervises.

3. DESCRIPTION AND OPERATION

3.1. Intended use

Medical Device Directive: current intended purpose:
The intended use of the Minddistrict Platform is defined in accordance with the definition of medical purpose in the Medical Device Directive rule 12 of 93/42/EWG:

[!IMPORTANT] Current intended use Minddistrict Platform:

Minddistrict is a web-based platform sold to healthcare organiations. Patients from these healthcare organisations can go through online modules for the prevention and treatment of mental or psychosomatic illnesses. These modules can be performed as pure self-help modules (however the patient still need to be introduced on the platform by his/her healthcare organisation) or accompanied by practitioners (e.g. physicians, psychotherapists etc) working for the same healthcare organisation. The practitioners can submit feedback and advices to patients at regular intervals.

Medical Device Regulation transition towards:
The intended use of the Minddistrict Platform is defined in accordance with the definition of medical purpose in the Medical Device Regulation: Article 2(12):

Future intended use Minddistrict Platform under the Medical Device Regulation:

The Minddistrict Platform is an ehealth software platform that facilitates hybrid mental healthcare delivery by offering healthcare organisations and healthcare professionals a catalogue of digital tools like screening instruments, psychoeducational content modules, video calling, chat, diaries, graphs and the CMS.

Within the Minddistrict Platform there is a defined subset of tools which constitute a standalone digital medical device (Software as a Medical Device). The digital tools that constitute medical device software are the screening instruments, which are intended to be used by healthcare professionals for monitoring patients presenting with mental-health and behavioural somatic conditions.

The screening instruments operate by collecting structured patient-related input (i.e. questionnaire responses or symptom severity ratings) and processing that input using predefined, rule-based algorithms, for example for norm scoring. The outputs are scores like symptom severity ratings based on predefined thresholds which are intended to be interpreted by the care professional, who can then decide whether to adjust treatment based on the results. Outputs are not intended to autonomously diagnose any medical condition.

The Platform, including the screening tools, is used within a healthcare professional–patient relationship in outpatient, inpatient, and rehabilitation settings (psychiatric and somatic), by qualified healthcare professionals (e.g. psychologists, psychiatrists, physicians, and other licensed mental-health professionals) who configure care pathways for individual patients by selecting different types of digital tools to best fit their patient's needs. Only healthcare professionals and organisations can assign Minddistrict Platform medical device screening tools to patients.

Each screening tool has a defined population (adults, adolescents or children) and is used to monitor patients for one or more of the following conditions: depression; bipolar disorder; generalised anxiety disorder and other anxiety disorders, including panic disorder, agoraphobia, social phobia and specific phobia; obsessive-compulsive disorder; post-traumatic stress disorder, including complex PTSD; substance use disorder and gambling disorder; eating disorder; sleep disorder; ADHD and associated executive-function impairment; autism spectrum disorder; somatoform disorder; psychosis (risk); personality disorder; behavioural and emotional disorders; mild intellectual disability; the behavioural/psychological burden of chronic pain or other somatic disease; and the behavioural/psychological burden of occupational stress.

A subset of screening tools provide transdiagnostic monitoring of general psychiatric symptom severity, functioning, disability or quality of life across these conditions, rather than screening a single named condition.

In accordance with Article 2(53) MDR, the clinical benefit of the Minddistrict Platform is its positive impact on patient management which is expressed in two main clinical benefits and one indirect benefit:

Clinical benefit claim 1: The Platform's screening instruments enable an indicative symptom severity classification for various indications which informs the healthcare professional's own decisions on adjusting care intensity.
Clinical benefit claim 2: The Platform's screening instruments support structured monitoring of symptom severity and course of treatment.
Clinical benefit claim 3 (indirect): Digitised administration of licensed, validated screening instruments supports the overall reliability of the monitoring data, rather than constituting an independent clinical benefit. No direct therapeutic effect is claimed for the screening instruments themselves; any benefit unfolds within the framework of the healthcare professional's own clinical decision-making.

Patients may invite non-clinical guests/support persons to the Platform in a view/support-only capacity; these individuals are not part of the intended patient population and have no influence on the software's medical functionality.

Only the defined screening tools constitute the Minddistrict Platform medical device but are designed to work safely in combination with the rest of the digital tools the Platform offers. Other digital tools such as psychoeducational content, video calling, chat, diaries, graphs and the CMS do not constitute part of the Minddistrict Platform medical device. The CMS allows healthcare organisations to develop their own content for their own use; such customer-developed content is not made available on the market by Minddistrict.

The Minddistrict Platform medical device is not intended for: use in emergency or acute situations requiring immediate clinical intervention (e.g. imminent suicide risk, acute psychosis); as a sole basis for clinical decision-making without healthcare-professional review; as a replacement for clinical judgement or face-to-face assessment; in patients unable to provide reliable self-reported input; or in situations requiring real-time physiological monitoring or immediate escalation.

3.1.1. Indication

The Minddistrict Platform medical device is intended for use with various indications depending on the module as specified in A.1.1. Device Description & Specification Minddistrict Platform.

Each screening tool has a defined population (adults, adolescents or children) and is used to monitor patients for one or more of the following conditions:

depression;
bipolar disorder;
generalised anxiety disorder and other anxiety disorders, including panic disorder, agoraphobia, social phobia and specific phobia;
obsessive-compulsive disorder;
post-traumatic stress disorder, including complex PTSD;
substance use disorder and gambling disorder;
eating disorder;
sleep disorder;
ADHD and associated executive-function impairment;
autism spectrum disorder;
somatoform disorder;
psychosis (risk);
personality disorder;
behavioural and emotional disorders;
mild intellectual disability;
the behavioural/psychological burden of chronic pain or other somatic disease;
and the behavioural/psychological burden of occupational stress.

A further subset (multi-domain triage instruments) screen across several of the above conditions within a single structured, two-stage (exploratory and in-depth) assessment, and additionally score severity, risk (e.g. suicide, aggression, self-neglect), complexity and course of symptoms to produce a preliminary care-pathway/referral-level recommendation for the treating healthcare professional; this recommendation is advisory only, must be verified by the healthcare professional through direct assessment of the patient before any referral decision is made, and the healthcare professional retains full discretion to deviate from it based on clinical judgement.

3.1.2. Limitations of use and contraindications

The Minddistrict Platform medical device is not intended for use in the following situations:

Emergency or acute situations requiring immediate clinical intervention (e.g. imminent suicide risk, acute psychosis). The software is not intended to function as an emergency detection or crisis response system.
Use as a sole basis for diagnosis, treatment decisions, or clinical triage without healthcare professional review.
Replacement of clinical judgement or face-to-face assessment.
Use in patients unable to provide reliable self-reported input (e.g. severe cognitive impairment, acute intoxication, severe psychotic or manic states).
Situations requiring real-time physiological monitoring or immediate escalation where delayed response could cause harm.

3.2. Settings and updates

3.2.1. Technical requirements

During the implementation training, the Minddistrict Service Desk will create an Application Manager account for you on the Minddistrict production, training and implementation platform. The account will be created with your organisation’s email account and you need a device with internet access [desktop or laptop (Windows PC, Mac and Linux). An internet connection is needed for the use of the Minddistrict Platform. An overview of the supported web browsers and devices can be found here:

Desktop & Laptop (Windows PC, MacBook and Linux)

Web browser with the latest version:
- Google Chrome;
- Edge;
- Safari;
- Firefox.

Please note that the technical requirements may change with newer versions of the medical device.

3.2.2. Installing

Information about logging in and accessing the Minddistrict Platform can be found on our support page: Login. A summary is provided below.

Once your account has been created, you will receive a welcome email. Click the link in the email to create your password. Your account will automatically open in the browser, allowing you to start working immediately.

Your account is password-protected, and we require the following conditions for your password:

A minimum of 12 characters;
At least one special character (e.g., !@#$%*).

[!NOTE] Application managers and healthcare professionals do have access to the web application only, as a smartphone app is not currently available for them. Patients and their friends/guests, however, can use both the web application and the smartphone app.

The Minddistrict Platform is available at any time and be used regardless of location.

3.2.3. Security updates

User devices and software should be updated to keep up with industry standards, as this is known to reduce the risk of being compromised. Protect your account credentials: do not share your password with anyone, enable two-factor authentication where available, and always log out when using a shared device at the end of each session.

As Application Manager, communicate shared-device guidance within your organisation: users of shared devices must always log out after each session. This is applicable for patients using shared devices but also for healthcare professionals using shared devices.

3.3. Managing the Platform

The Application Manager has the following main tasks relating to the management of the Minddistrict Platform:

Create and manage professional accounts;
Managing configurations;
Assigning groups and defining rights;
Using the training platform to reproduce cases;
Receive the release notes and spread relevant information in your organisation.

Detailed information and steps how to perform these actions can be found on of the support page: https://adminsupport.minddistrict.com/en/support/solutions/articles/17000091934-application-management-and-service-rights-and-tasks#heading7https://adminsupport.minddistrict.com/en/support/solutions/articles/17000091934-application-management-and-service-rights-and-tasks#heading7.

3.4. Platform configurations

The Minddistrict Platform can be configured to meet your specific needs. As the Application Manager, you have the rights to make these changes. The Minddistrict Platform includes several default configurations, with the option to add additional functionalities. These configurations can be enabled upon request through the Minddistrict Service Desk. Configuration regarding the following items are available:

Platform setup;
Patient accounts;
Professional accounts;
Integrations;
Configurations set or made available by Minddistrict.

Screenshot of the platform configurations

Detailed information and steps how to perform these actions regarding configurations can be found on of the support pages: https://adminsupport.minddistrict.com/en/support/solutions/folders/17000134614.

3.5. Data and exports

The Data Dashboard is an external tool that allows you to view anonymous usage data from your organisation’s Platform(s). For example, it shows the number of unique users active during a selected period, the number of times a tool has been used or the total video call minutes (when applicable). Additionally, it is possible to create data exports. Only individuals with the role of Data Analyst or Data Officer can create an export.

Detailed information and steps how to perform these actions can be found on of the support page: https://adminsupport.minddistrict.com/en/support/solutions/folders/17000138091.

3.6. Warnings and precautions

This section describes the warnings and precautions with regard to the use of the Minddistrict Platform:

The Minddistrict Platform is not intended for use during an emergency or hazardous situation. In case of an emergency of hazardous situation, patients should always contact their healthcare provider or emergency services.
Do not design organisational workflows that rely solely on the Platform’s triggers, thresholds or notifications to detect a deterioration in a patient’s condition. The Platform is intended for a blended-care setting in which healthcare professionals continue clinical monitoring through their usual modalities, independently of Platform alerts.
The Data Officer role has the ability to export, edit, distribute, and store all personal (health) information within the Minddistrict Platform. Assign this role with caution. More generally, assign all roles and authorisations on a least-privilege basis: granting more roles or rights than a person needs increases the risk of unauthorised access to patient data.
When implementing third-party integrations, follow the Minddistrict implementation documentation and test the integration before use in care delivery: faulty implementation or configuration of an integration can lead to incorrect data in a patient’s Minddistrict file. Please make sure you have read the specific compliance documentation from Minddistrict with regard to the applicable integration. This document is provided by your implementation manager of Minddistrict or available upon request via compliance@minddistrict.com.
The Minddistrict Service Desk will never request personal (health) information from a patient. When contacting the Minddistrict Service Desk, never send any personal (health) information. Instead, provide the client ID along with the Platform URL.
The trainingsplatform is meant for training purposes. Never add real patient accounts to the trainingsplatform of your Minddistrict environment.

3.7. Hosting and data storage

All platform / production server data including personal (health) data of users is stored at our hosting provider Intermax Cloudsourcing B.V. in secured data centers in the Netherlands. These data centers include all the necessary physical security controls you would expect in a state-of-the-art data center (24×7 monitoring, cameras, visitor logs, entry requirements). Our hosting provider Intermax has certifications for ISO 27001, ISAE 3402 Type II and ISO 14001.

4. QUALIFICATION OF THE DEVELOPERS

Minddistrict develops its tools based on evidence-based guidelines in direct collaboration with patients and therapists. The software is developed by our engineers who follow best practices and industry-standard secure coding guidelines which align with the OWASP Top 10. Furthermore, our developers are trained to meet the requirements of our implemented Information Security Management System and Quality Management System.

5. DATA PROTECTION

Access to the account is password-protected and by two-factor-authentication (when enabled). Access to the app (only for patients) is protected by an individually defined 5-digit pin. Minddistrict meets the data protection requirements of the General Data Protection Regulation (GDPR). In addition, Minddistrict is ISO 27001:2022 and NEN 7510:2017 certified and has a ISAE 3000 Type II statement in place with a focus on information security. Further details on the processing of personal data can be found in your account of the Minddistrict Platform. If questions arise you can send those to compliance@minddistrict.com.

6. SYMBOL LEGEND

Symbol	Description
	Manufacturer ISO 7000-3082 Indicates the medical device manufacturer.
	Medical device ISO 15223- 1:2020 Reference no. 5.7.7 Indicates the item is a medical device.
	CE Marking European Community The CE Marking on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.
	Consult instructions for use or consult electronic instructions for use ISO 7000-1641 Indicates the need for the user to consult the instructions for use.
	Date of manufacture ISO 7000-2497 Indicates the date when the medical device was manufactured.
	Caution ISO 7000-0434A Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.