Instructions for use

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 VIII of the Regulation (EU) 2017/745.

1.1. Feedback and incidents

These Instructions for Use are 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

These Instructions for Use are 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

2.1. When can you use the Minddistrict Platform?

You can use the Minddistrict Platform only after your healthcare organisation or healthcare professional has created an account for you and instructed you to use it. The screening instruments that form the Minddistrict Platform medical device can only be assigned to you by your healthcare professional or healthcare organisation.

Minddistrict provides you with an ehealth platform, where you can work on recovery or personal growth. You do this together with, and under the guidance of, your therapist or healthcare professional; someone from your own network may additionally support you. If your healthcare organisation has activated self-help psychoeducational content on your platform, you can also work through this content by yourself. Self-help content is not part of the medical device. Minddistrict offers interventions tailored to different age groups, adults, adolescent and children.

The following roles and actions are available in the Minddistrict Platform:

2.2. When can you not use the Minddistrict Platform?

You cannot make use Minddistrict if:

• Your healthcare organisation or healthcare professional has not created an account for you and instructed you to use the Platform;
• You do not have access to technical tools; no laptop, tablet, or phone;
• You do not have an email address;
• You do not have access to an internet connection;
• If you are not proficient in any of the language(s) provided by the Minddistrict Platform.
  The following languages are available:
  • Dutch;
  • English;
  • German.

[!NOTE] Please note that only the Minddistrict Platform itself switches to the language chosen by the end user. The tools in the catalogue remain in the language in which they were created and are not automatically translated. The MDR certified tools in the platform are only available in the above mentioned 4 languages.

3. DESCRIPTION AND OPERATION

3.1. Intended use

Medical Device Directive: current intended use:
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/EEC:

[!IMPORTANT] Current intended use Minddistrict Platform:

Minddistrict is a web-based platform sold to healthcare organisations. 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. Indications

The Minddistrict Platform medical device is intended for use with various indications depending on the module. Not all modules apply to all indications. Each screening instrument 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.

You do not need to determine yourself which of these conditions applies to you. Your healthcare professional decides which screening instruments are relevant for your situation and assigns them to your account. Only those assigned instruments apply to you. The list above describes everything the Platform's screening instruments can be used for across all patients. If you are unsure why a questionnaire was assigned to you, ask your healthcare professional.

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

You need a personal email address and a device with internet access [desktop or laptop (Windows PC, Mac and Linux), smartphone or tablet]. 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.

Mobile Devices

• iPhone 6s or later with the latest version;
• Android smartphone with the latest version.

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 pages: Login. A summary is described below.

3.2.2.1. Webapplication

Your healthcare provider will create an account for you on the Minddistrict Platform. 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., !@#$%*).

3.2.2.2. Smartphone app

From the welcome email you log in for the first time via the browser and create a password.

You can then log in to the Minddistrict app in 2 ways:

1. With a QR code;
2. With the e-mail address and password you have created.

After logging in, you create a 5-digit pin code. This pin code makes it easier to log in next time. You no longer have to enter your e-mail address and password.

iOS

Open the App Store on your iOS device and search for "Minddistrict". Click "Download" to start the installation process. The App Store requires you to use your chosen password, fingerprint, or FaceID. Then the Minddistrict app is downloaded and installed. Here you can find the link to the app:

Minddistrict App - App Store

Android

Open the Play Store on your Android device and search for "Minddistrict". Click the icon to view the details. After that, you can press "Install" to start the installation process and accept Google's download terms. Then the Minddistrict app is downloaded and installed. Here you can find the link to the app:

Minddistrict - Apps on Google Play

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. Keep the operating system and web browser of your device up to date and install security updates when they become available. Protect your device with a passcode or biometric lock. Do not share your password or pin code with anyone.

Make sure you log out when using a shared device (e.g. from a healthcare organisation) at the end of each session you have worked in your Minddistrict account.

3.3 Tools and functionalities

Information about the main tools and functionalities of the Minddistrict Platform can be found on our support pages: Functionalities. A summary of this is described below. Please note that it is at the therapist's discretion which tools and functionalities are provided to you.

3.4. Warnings and precautions

The Minddistrict Platform is not intended for use during an emergency or hazardous situation. In case of an emergency of hazardous situation, you should contact your healthcare provider or emergency services directly.

The Minddistrict Platform is not suitable for use in acute crisis situations, including acute suicidal thoughts. If you are in crisis or need urgent help, contact your healthcare provider or the emergency services immediately.

The Minddistrict Platform is not designed to automatically detect a worsening of your symptoms or to alert you or your healthcare professional in every situation. Do not wait for a message or notification from the Platform: if your symptoms worsen, or if you are worried about your health, contact your healthcare professional directly, even if the Platform has not shown any warning.

3.5. Side-effects

Not all users benefit equally from using the Minddistrict Platform functionalities. If use does not lead to the hoped-for improvements, this can cause a feeling of disappointment under certain circumstances. In addition, it is possible that stressful topics arise in the context of the Minddistrict Platform, which can stir up inside. The use of psychotherapeutic techniques can lead to undesirable effects, such as an initial worsening of the symptoms.

If the burden becomes too great during the course of using the Minddistrict Platform, we recommend taking a break and talking to your therapist about it. If side effects occur as part of the Minddistrict Platform, they can be reported to your therapist and by email to compliance@minddistrict.com.

3.6. 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 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.