Instructions for use

1. Information about these Instructions for Use

These instructions for use are intended to help you use the Evela Health Platform safely and as intended. All content is written in clear and understandable language.

These instructions for use are updated regularly when there are new versions or functions. Please therefore always use the current version.

If you have questions or need support, you can contact our support team at any time: support@evela.health.

These instructions for use meet the requirements of Regulation (EU) 2017/745 (MDR).

1.1 Trade name and version

The trade name of this product is: Evela Health Platform

These instructions for use apply to software version 2.0.2.

Version of these instructions for use: 1.3 — Issue date: 30.09.2026

This English version is a translation of the German instructions for use (Gebrauchsanweisung), version 1.3. In case of doubt, the German version applies.

1.2 Manufacturer information

Manufacturer: Evela Health GmbH

Chausseestraße 58D

10115 Berlin

Germany

Email: support@evela.health

Website: www.evela.health

In the event of serious incidents in connection with the use of this product, please contact the manufacturer and the competent national authority without delay.

1.3 Electronic provision (eIFU)

These instructions for use are provided exclusively in electronic form (eIFU).

The current version is available online at any time at: www.evela.health/en/instructions-for-use.

Previous versions of these instructions for use remain available; version and issue date are stated above (Article 5 of Commission Implementing Regulation (EU) 2021/2226). A printed version of these instructions for use will be sent free of charge on request. Please send requests to support@evela.health; the printed version will be sent within seven calendar days.

1.4 Labels and symbols

The Evela Health Platform bears the legally required labelling:

  • CE marking in accordance with the MDR
  • MD symbol for medical device
  • Manufacturer symbol with name and address
  • Date of manufacture symbol stating the software release date
  • UDI-DI (GTIN): 04262550850009
  • Basic UDI-DI (GMN): 426255085EV-MP-1T

An overview of the symbols used, with explanations, can be found in Chapter 9 "Symbols and legal notes".

2. Intended purpose

The intended purpose of the Evela Health Platform is the structured recording of self-reported menopausal symptoms with the Evela Score, the rule-based calculation of the Evela Score sum value, its display over time and the assignment of the value to three non-clinical orientation ranges. The Evela Score is a questionnaire based on the validated Menopause Rating Scale II (MRS II) and extended by one further question; each question is rated on a five-point scale from 0 to 4, and the sum value ranges from 0 to 48. The software thereby serves the investigation of a physiological process within the meaning of Article 2(1), third indent, of Regulation (EU) 2017/745.

The software does not provide information intended to be used for decisions with diagnostic or therapeutic purposes, and it does not control or monitor physiological processes. It uses no clinical cut-off values, produces no risk scores, alerts or thresholds, and gives no recommendations. The orientation ranges have no diagnostic meaning and do not trigger any action.

The Evela Health Platform supports you in

  • using information and general content on menopause, health and lifestyle topics (e.g. nutrition, exercise, sleep, skin and hair, prevention, resilience),
  • recording your symptoms using the validated Menopause Rating Scale (MRS II) and documenting them over time, as well as documenting personal habits and priorities,
  • preparing for conversations with experts through structured questionnaires (Health Assessment),
  • arranging and conducting consultations with experts.

Only the second item of this list is part of the medical device: recording your symptoms with the Evela Score, calculating the sum value, displaying it over time and assigning it to three non-clinical orientation ranges. The other functions — the information content and courses of the Evela Campus, the questionnaire (Health Assessment) and the consultations with experts — are not part of the medical device. They are mentioned here only so that you can recognise the environment in which the medical device is used. Assessments or recommendations in this environment are made by people, not by the software.

The Evela Health Platform itself does not make diagnoses, does not interpret entries and does not give automated recommendations. Individual recommendations are given exclusively in the consultations with the connected experts.

The software does not replace a medical examination or treatment. All content on the platform is general and not tailored to individual persons.

You use the platform independently as the user. Medical decisions always lie with physicians or healthcare professionals and are not an integral part of the Evela Health Platform. Indications that a medical examination is necessary can only be given by human experts, not by the software itself.

3. Product description

The Evela Health Platform was developed specifically for women in midlife. It serves the structured recording and documentation of menopausal symptoms with the Evela Score and the preparation for consultations with experts; in addition, it provides general information content on nutrition, exercise, sleep, mental health, sexuality, skin and hair, prevention and the handling of medicines and dietary supplements.

After successful registration (see Chapter 4), several areas are available that offer you different ways to actively reflect on and support your health and wellbeing. A detailed description of how to use the functions can be found in Chapter 5 "Main functions".

3.1 Overview of functions

The Evela Health Platform is divided into four main areas:

  • Home with symptom diary (MRS II)
    Here you can record your symptoms with the Evela Score. The Evela Score is based on the scientifically established Menopause Rating Scale II (MRS II) and extended by one further question. Repeated entries help you to observe changes over time and to recognise patterns.
  • Evela Campus
    This area contains articles, videos and audios on topics such as menopause, nutrition, exercise, sleep, mental health, sexuality, skin and hair, prevention, and medicines and dietary supplements. The content is evidence-based and reflects the current state of science. Depending on your entries, content may be displayed in a personalised way.
  • My Data
    In this area, your entries from the symptom diary and further questionnaires are collected and visualised in an easy-to-understand form. This gives you an overview of developments over time, which can also help you in conversations with experts or physicians.
  • Experts
    Here you can book and conduct consultations on lifestyle topics online. The consultations offer the opportunity to clarify individual questions and to receive personal recommendations.

3.2 Premium area

In addition to the basic functions, there is a paid premium area that offers extended options. These include:

  • a Health Assessment, i.e. a structured questionnaire covering various areas of life,
  • video consultations with experts that are based on your entries and give you individual recommendations,
  • a personal health plan that gives you a structured overview with recommendations based on the expert consultation,
  • access to all premium content in the Evela Campus.

If required, cooperating physicians can also be involved via the platform, e.g. for prescribing medicines.

3.3 Technical requirements

To ensure that the application works smoothly, please note the following:

  • The Evela Health Platform is available as a browser application and as a native mobile app for iOS and Android. The app can be downloaded from the Apple App Store (iOS 15+) and the Google Play Store (Android 11+).
  • A current internet browser is required (e.g. Chrome, Safari, Edge, Firefox).
  • A stable internet connection is necessary.
  • A user account is required for access. When registering, you provide a valid email address.
  • Choose a secure password and do not share it with anyone so that your access remains protected.
  • The platform is optimised for use on desktop, tablet and smartphone.
  • Video consultations with experts take place via a secure connection using an approved communication service.
  • The Evela Health Platform can generally be used with common accessibility aids (e.g. screen readers, zoom functions). Depending on the impairment, however, some content or displays may only be accessible to a limited extent.

4. Registration and first steps

To use the Evela Health Platform, you first create your own user account. This is necessary so that your data is stored securely and is accessible only to you. The registration process consists of three steps: creating the user account, setting a secure password and agreeing to the necessary consents.

4.1 Creating a user account

Registration begins with entering your email address. It is used as your user name and also serves to confirm your registration.

You then set a password and repeat it for confirmation.

To keep your access secure, your password must meet the following criteria:

  • at least 8 characters long,
  • contain at least one number,
  • the passwords must match.

After you have confirmed your details, you will receive an email with a six-digit confirmation code. Enter this code in the field provided. This activates your account. If the email does not arrive, you can request the code again.

4.2 Password and security notes

Your password protects your personal data and all entries you make on the platform. Please choose a password that only you know and keep it safe. Do not share it with third parties, not even with friends or family members.

If you forget your password, you can renew it at any time using the "Reset password" function.

4.3 Data protection and consent

Before you can use the platform, you will be asked to consent to certain points:

  • Terms of use: You must accept these in order to use the Evela Health Platform.
  • Health data: To use functions such as the symptom diary (MRS II), you must consent to your health data being processed in accordance with the privacy policy.
  • Analysis and personalisation: This consent allows your activities on the platform to be evaluated in order to provide you with personalised content.
  • Research (optional): You can voluntarily consent to your pseudonymised data being used for scientific purposes. In doing so, you support the further development of the understanding of menopausal symptoms.

All consents are presented transparently. You can see exactly which details are mandatory and which are voluntary. Further information on the processing of personal data, retention periods, encryption and your rights can be found in our privacy policy at https://app.evela.health/privacy.

Processing is carried out in accordance with the GDPR and the technical and organisational measures (TOMs) in accordance with MDR Annex I, Chapter III.

5. Main functions

After registration, the Evela Health Platform provides you with various functions that support you in recording your symptoms, accessing understandable information and preparing for consultations. While the basic version already includes all core functions, the premium area offers additional options that allow even more detailed reflection and targeted preparation for conversations with experts.

The individual main functions are described below:

5.1 Home and symptom diary

The home page is your personal starting point on the platform. Here you will find the symptom diary, which is based on the internationally established Menopause Rating Scale (MRS II).

  • The Evela Score is used to record typical menopausal symptoms, such as hot flushes, sleep disturbances or mood swings, in a structured way.
  • Entering your symptoms repeatedly creates an overview over time that helps you to recognise patterns and changes.
  • The more regularly you make entries, the better you can follow changes and document your development.
  • The results are displayed in clear graphics so that you can see changes at a glance.

Using the symptom diary is voluntary, but it provides you with a valuable basis for self-reflection and for preparing for conversations with experts or physicians.

5.2 Evela Campus (articles, videos, audios)

The Evela Campus contains a collection of articles, videos and audios on topics relating to menopause and lifestyle. These include nutrition, exercise, sleep, mental health, sexuality, skin and hair, prevention and the handling of medicines and dietary supplements.

  • The content is evidence-based and reflects the current state of science.
  • The presentation of content can be based on your entries and needs, so that relevant topics are displayed to you in a personalised way.
  • The Campus is accessible at any time and serves as a source of knowledge that accompanies you in everyday life.

5.3 My Data (overviews, trends and premium content)

In the My Data area, you will find all the entries you have made on the platform in structured form.

  • Data from the symptom diary (MRS II) and from additional questionnaires, such as the Health Assessment (premium only), appear here.
  • The entries are displayed in overviews and trends over time. This gives you a structured overview of your development at all times.
  • If you have completed the Health Assessment in the premium area, you will also find the related entries here, as well as the personalised recommendations from the consultations based on them.
  • The Health Assessment data can be downloaded if required and can also be supplemented or adjusted digitally.

5.4 Experts (appointment booking & consultation)

In the Experts area, you can book and conduct consultations.

  • Appointments are booked directly via the platform.
  • The consultations take place via secure video communication.
  • The consultations cover various areas of life that can play a role during menopause (e.g. nutrition, exercise, sleep, resilience, sexuality).
  • The experts take your entries into account, for example from the symptom diary or the Health Assessment, and give you individual recommendations in the consultation that address your personal situation.

5.5 Premium Health Assessment (questionnaire & preparation)

In the premium area, a detailed Health Assessment questionnaire is also available to you.

  • The questionnaire covers various topics, including symptoms, lifestyle, sleep, exercise, nutrition and mental health.
  • Your entries help you to assess yourself better and to prepare specifically for consultations.
  • Based on your answers, the experts can respond to you individually in the consultation and create a personal health plan for you.
  • This plan clearly summarises the most important recommendations and notes for your everyday life.

6. Safety information

The Evela Health Platform is software developed for independent use by adult women. It supports you in recording your symptoms, accessing information and preparing for consultations with experts. To use the application safely, it is important to observe some notes.

6.1 General safety notes

The Evela Health Platform serves the structured documentation of self-reported menopausal symptoms as well as information and preparation for consultations. It does not make diagnoses, does not interpret entries clinically and does not give medical recommendations.

For safe use, please also note:

  • Keep your login details safe and do not share your password with others.
  • Only use the platform on trusted devices.
  • Keep your device and your internet browser up to date.
  • Make sure that you have a stable internet connection.

6.2 Situations in which the application is not suitable (so-called "contraindications")

The Evela Health Platform is not intended for use in situations that require immediate medical clarification. If you have acute symptoms, you must not rely on the platform but must seek medical help immediately.

These include in particular:

  • acute emergencies, for example chest pain, shortness of breath or heavy bleeding,
  • severe mental crises or distress that require immediate support,
  • any situation in which a direct medical examination or treatment is necessary.

In such cases, please call the emergency number 112 immediately or contact your treating physician directly.

6.3 Warnings for safe use

The Evela Health Platform does not replace a medical examination or treatment. If you are unsure, or if your symptoms get worse, last longer or are unusually severe, always contact healthcare professionals — regardless of the value or trend displayed on the platform. The content in the Evela Campus is based on scientific findings and is for your general information; however, it does not constitute individual medical advice.

6.4 Possible consequences of incorrect use

If the Evela Health Platform is not used as intended, the following risks may arise:

  • Symptoms may be misinterpreted, as the platform does not make diagnoses and does not give medical recommendations.
  • A necessary medical examination may be delayed if symptoms are recorded only on the platform or if a score is wrongly interpreted as a sign that no treatment is needed.
  • Content may be misunderstood, which can lead to uncertainty or misinterpretation.
  • Improper handling of login details creates the risk that third parties gain unauthorised access to personal information.

These risks can be avoided if you use the application as described in these instructions for use and always consult physicians if you have health complaints.

7. Reporting of incidents

Although the Evela Health Platform has been carefully developed and tested, problems may occur in rare cases. To ensure your safety at all times, it is important that such incidents are reported.

A "serious incident" exists, for example, if

  • the use of the application leads or may have led to a serious deterioration of your health,
  • safety-relevant problems occur that could also affect other users,
  • errors occur in the software that lead to incorrect or misleading information.

7.1 Contacting the manufacturer

If you notice an incident, please contact us immediately and describe as precisely as possible what happened.

Evela Health GmbH

Email: support@evela.health

Website: www.evela.health

7.2 Reporting to authorities

In addition to reporting to the manufacturer, serious incidents must be reported to the competent national authority of your country:

  • Germany: BfArM – Federal Institute for Drugs and Medical Devices, www.bfarm.de
  • Austria: BASG – Federal Office for Safety in Health Care, www.basg.gv.at
  • Switzerland: Swissmedic – Swiss Agency for Therapeutic Products, www.swissmedic.ch

8. Data protection and data security

The Evela Health Platform processes only the data required to use the application. This includes in particular your account details (email), content from the symptom diary (MRS II) and — when using the premium area — information from questionnaires and from the consultations. All information is voluntary; without the consents, individual functions are not available.

Processing is carried out in accordance with the General Data Protection Regulation (GDPR). The legal bases are your consents to the use of the platform and to the processing of health data. You can withdraw consents at any time with effect for the future. You have the right of access, rectification, erasure, restriction of processing, data portability and the right to lodge a complaint with a supervisory authority.

To protect your data, the platform uses technical and organisational measures, including encrypted transmission (TLS), access restrictions, logging of access and regular backups. An approved communication service with a secure connection is used for video consultations.

Details on data processing, retention periods, contact with the data protection contact point and information on voluntary consents (e.g. research) can be found in the privacy policy on our website: https://www.evela.health/de/privacy-policy.

9. Legal provisions, notes and symbols

The Evela Health Platform is a Class I medical device in accordance with Regulation (EU) 2017/745 (MDR), Annex VIII, Chapter III, Rule 11, final paragraph. Its intended purpose is the structured recording of self-reported menopausal symptoms with the Evela Score, the calculation and display of the sum value over time and the assignment to three non-clinical orientation ranges. The application does not replace a medical examination or treatment.

Development and provision are based on the relevant legal requirements and — where applicable — on the following standards and guidelines:

  • Regulation (EU) 2017/745 on medical devices (MDR), Rule 11
  • DIN EN ISO 13485:2016/A11:2021 (Quality management systems for medical devices)
  • DIN EN ISO 14971:2019 (Risk management for medical devices)
  • IEC 62304:2006+A1:2015 (Software life cycle processes)
  • IEC 82304-1:2016 (Health software – General requirements)
  • IEC 62366-1:2015+A1:2020 (Usability of medical devices)
  • EN ISO 20417:2021 (Information to be supplied by the manufacturer)
  • EN ISO 15223-1:2021+A1:2025 (Symbols for the labelling of medical devices)
  • Commission Implementing Regulation (EU) 2021/2226 (electronic instructions for use, eIFU)

Note: The application is intended exclusively for adult users. Safety and usage notes are summarised in Chapter 6. Incidents must be reported in accordance with Chapter 7.