Instructions for Use for Healthcare Professionals

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

2.1. When can you use the Minddistrict Platform?

The primary intended users of the Minddistrict Platform are healthcare professionals employed by health institutions that are qualified to take on various roles in the treatment delivery via the Minddistrict Platform.

Providing the right roles to the right persons is under the solely responsibility of the health institution. It’s also possible that one healthcare professional may undertake more than one role. Minddistrict offers customer and implementation training as well as extensive documentation on the website which describes the roles available and functions. The table below provides an overview of the available roles and their main actions.

Available role	Main action
Application Manager	Configures the Minddistrict Platform and creates healthcare professional accounts.
Auditor	Could access data reports such as NEN 7513 logging reports.
Connected Healthcare Professional	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 personally identifiable information.
Data Officer	Configures data collection and initiate data exports.
Editor	Can create, adapt or upload content for the customer's own Platform using Minddistrict’s Content Management System. There are two types of third-party content: Customer content: made by a customer or by Minddistrict for a customer for their own Platform only. Minddistrict does not place it on the market. Resold content: third-party content that Minddistrict resells. Minddistrict places it on the market and is responsible for it.
Programmer	Makes calculations and come up with a raw code of a document or template in a number of places in the Content Management System.
Release Manager	Edits and releases content.
Secretary	Processes new patient registrations, links new patients to healthcare professionals, prepares tools for them and activates or deactivates accounts.
Supervisor	Supervises healthcare professionals. Has 'read only' access to the files of patients being treated by the connected healthcare professionals that he or she supervises.

The makeup of the patient population using the Minddistrict Platform at a given health institution depends on that organisation and the particular treatment provider delivering the treatment. A health institution / care provider has full professional discretion to determine whether a given patient is well-suited to treatment using the Minddistrict Platform.

Only healthcare professionals and healthcare organisations can assign the Minddistrict Platform medical device screening instruments to patients. Patients cannot self-assign these instruments; self-help psychoeducational content (not part of the medical device) is available to patients only if activated by the healthcare organisation.

2.2. When can patients not use the Minddistrict Platform?

Patients cannot make use of the Minddistrict Platform:

The healthcare organisation or healthcare professional has not created an account for the Patient and instructed the patient to use the Minddistrict Platform;
The health institution / care provider has determined the patient is not suitable for using the Minddistrict Platform;
The patient does not have access to technical tools; no laptop, tablet, or phone;
The patient does not have an email address;
The patient is not proficient in the language 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/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 psubstance use disorder and gambling disorder;rofessionals 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 disorders; 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 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 update

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;
- Microsoft 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.

If you would like to use Minddistrict, you need a professional account on a Minddistrict Platform. Your organisation's Application Manager or helpdesk can create a professional account for you to log in with.

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] Professionals 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. 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.

Make also sure that you logout patients that have ended their session before you provide a shared device to another patient.

3.3. Tools and functionalities

Minddistrict is an ehealth platform that facilitates blended care. As a professional, you can choose digital interventions and tools to support your treatment plan and tailor healthcare directly to your patients' needs.

Information about the tools and functionalities of the Minddistrict Platform can be found on our support pages: https://support.minddistrict.com/en/support/solutions/articles/17000125085-how-do-i-use-modules-diaries-action-plans-and-other-tools-#heading7. A summary of this is described below.

Functionality	Description
Action Plan	In a couple of mobile modules, patients have the option of drawing up an Action Plan. The Action Plans allow patients to set a personal goal to work towards and evaluate their progress on a regular basis. The Action Plan regularly reminds patients to track progress.
Diaries/Trackers	A Diary or Tracker is a tool to gain insight into your patient's patterns and progress.
Messaging function	You can start a conversation with your patient within the module. You can also provide feedback to your patient with the use of the messaging function. Please note that feedback moments sometimes need input from the healthcare professional before a patient can proceed.
Module	Modules are validated online interventions and can have a transdiagnostic approach or are focused on a specific diagnosis. Patients receive psycho-education, can watch videos and do exercises. As a healthcare professional you may provide online feedback on these exercises.
Plans and Schemas	A Plan or Schema can help you keep an overview within a patient's treatment, or work towards goals.
Questionnaires/ROM	Minddistrict offers several questionnaires that healthcare professionals can use as part of treatment. You can provide these questionnaires repeatedly in a schedule to create a measurement pathway to gain valuable insights into a patient's well-being.
Self-help catalogue	Self-help modules can be started by the patient. The patient can work independently with a module of its choice. The modules are designed in such a way that they can be completed without supervision. But if a patient still needs feedback, they can always use the chat function to contact their healthcare professional.
Video calling (when applicable)	With video calling you can remotely have a conversation within the platform with your patient. You can also start a video call with fellow healthcare professionals. Not every organisation offers the option of video calling. In that case, you will not see this feature available in the platform.

The screening instruments constitute the Minddistrict Platform medical device: 158 licensed, pre-existing, clinically validated instruments digitized by Minddistrict, plus the in-house-developed Minddistrict Triage questionnaire. A screening instrument may also be embedded within a psychoeducational module (for example, the PHQ-9 within a CBT-based depression module); the same intended purpose and precautions apply in that case.

3.4. 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 contact their health institution/care provider or emergency services.
The Minddistrict Platform is not suitable for use in acute crisis situations, including acute suicidal thoughts. Patients in crisis should be directed to contact their healthcare provider or emergency services immediately.
Do not rely on the Platform’s triggers, thresholds or notifications to detect a deterioration in a patient’s condition. The Platform operates in a blended-care setting: continue clinical monitoring of your patients through your usual modalities, independently of Platform alerts, and advise patients to contact you directly if their symptoms worsen.
Screening-instrument outputs must never be used as a sole basis for diagnosis, treatment decisions or clinical triage; always interpret outputs in the context of your own clinical assessment.
It can happen that an intervention is not appropriate for the abilities of the patient, resulting in accessibility issues.
The content (video, exercises, psycho-education) in the interventions can cause an increase in symptoms due to the patient being sensitive to it.
It can happen that the data provided to professionals from decision support questionnaires is based on incorrect data input.
Despite secure development procedures, it can happen that bugs appear in the functionalities of the product which impact use.
Faulty implementation or use of a third party integration might lead to incorrect data in the Minddistrict file of the patient.

3.5. Contra-indications

3.6. Side-effects

Not all patients benefit equally from using the Minddistrict Platform. 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 for the patient becomes too great during the course of using the Minddistrict Platform, we recommend that patients taking a break and talking to their healthcare professional about it. If side effects occur as part of the Minddistrict Platform, patients can report this to their healthcare professional. When necessary, healthcare professionals can report side-effects to their organisation’s helpdesk or send an email to compliance@minddistrict.com.

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 controls close to where the symbol is placed, or that the current operator awareness or operator action in order to avoid undesirable consequences.