CorewayInsights: Instruction for Use (English)

CorIns-25
Version ID: 02.03.01.036
UDI: 04170000230380
Multiple use by one patient
Version of the IFU: 1
Date of issue: 2025-08-07

Provided by:
coreway UG (limited liability)
Bischof-Keppler-Straße 9
73525 Schwäbisch Gmünd
Baden-Württemberg
Germany
Correo electrónico: kontakt@core-way.de
Página web: www.core-way.de

These instructions for use are provided electronically (eIFU) and can be accessed at any time in the app under „Support“. The instructions for use are updated accordingly when the software is updated. These instructions for use apply exclusively to the CorewayInsights medical device.

Dear CorewayInsights users, 

CorewayInsights is a digital medical product for sufferers of chronic inflammatory bowel disease, which is used for self-management of the disease. The app collects entered data on dietary habits and assessments of well-being and compares these with the S3 guidelines for Crohn’s disease and ulcerative colitis on an individualized basis. The aim is to provide recommendations for action based on the guidelines and make it easier for users to identify personal relapse triggers. 

The following sections summarize the most important information for optimal use of CorewayInsights. If your questions are not answered here, please contact our team at . kontakt@core-way.de

Have fun with CorewayInsights!

Diese Gebrauchsanweisung enthält alle relevanten Informationen zur sicheren und zweckmäßigen Verwendung von CorewayInsights als Medizinprodukt. Bitte lese dir diThese instructions for use contain all relevant information on the safe and appropriate use of CorewayInsights as a medical device. Please read these instructions completely and carefully before using the application for the first time. This is the only way to ensure proper handling and minimize potential risks.

Meaning of these instructions for use:

• It describes the intended use of the product in accordance with the European Medical Device Regulation (EU) 2017/745.
• It contains safety-related warnings and contraindications.
• It explains the technical and medical requirements for use.
• It provides information on possible residual risks and gives advice on how to use the product responsibly.

Structure of the instructions for use

These instructions for use have a modular structure and follow the requirements of Regulation (EU) 2017/745 and the DIN EN ISO 20417:2021 standard. They contain all the necessary information for the safe, appropriate and effective use of CorewayInsights.

The content is divided into logical, consecutive chapters to enable easy navigation for users without prior medical knowledge. Each chapter deals with a specific aspect of use.

The following main areas are included:

• Product description and purpose: What is CorewayInsights and what is it for?
• Safety instructions and warnings: What must be observed during use?
• Risks, side effects and incident reporting: What can happen in exceptional cases?
• Technical and organizational requirements: What equipment and skills are required?
• Registration and use: How does the application work in practice?
• Functionalities at a glance: What does the app offer in detail?
• Conformity and standards used
• Liability and warranty
• Contact information and legal information

The instructions for use are updated regularly and can be accessed digitally at any time via the app.

In order to use CorewayInsights, you must have a medical diagnosis of one of the two chronic inflammatory bowel diseases Crohn’s disease or ulcerative colitis.

If you have not yet received a diagnosis from your doctor, please do so before using CorewayInsights. 

You also have the opportunity to address concerns and questions regarding the program and its use to our team.

Recommended updates:

To ensure safe and optimal use of CorewayInsights, update your app as soon as a new update is available, as it contains important may contain content. To ensure that you are always up to date, we recommend activating automatic updates for CorewayInsights.

Symbol word	Meaning
WARNING	Possible hazard with serious damage as a result.
CAUTION	Possible hazard with minor or moderate damage as a result.
NOTE	Important information on using the product.

NOTE: Color Coding

A red color coding in the app is used to visualize risks and warnings.

Even when using the CorewayInsights app correctly, the following effects may occur in rare cases, which we would like to draw your attention to:

Incorrect interpretation of the app results

It is possible that personal recommendations or summaries of data may be misunderstood or overrated by users.

NOTE: App doesn’t replace therapy

Please note that the app does not replace a medical diagnosis or therapy. If in doubt, always seek medical advice.

Delay in necessary medical treatment

Users could be falsely lulled into a false sense of security by the app and delay seeking medical help.

WARNING: Sudden worsening

If you experience severe discomfort or a sudden deterioration in your state of health, you should contact a doctor immediately.

Data entry errors by users

Incorrect or incomplete information on diet, symptoms or lifestyle data can lead to incorrect evaluations.

NOTE: False or incomplete statements

Please ensure that the information is correct and complete – this is crucial for the validity of the app.

Influence due to technical faults

In very rare cases, technical problems may occur,  as the app crashing or data loss.

NOTE: Regular Updates

Make sure that the app and your device are updated regularly.

Uncertainty due to recommendations

Some users may feel unsettled or overwhelmed by certain suggestions made by the app.

NOTE: Suggestions are not mandatory

The suggestions are intended as support. There is no obligation to implement them. Ask your healthcare professional if you are unsure.

A serious incident is deemed to have occurred if, for example, the use of the app:

• damage to health occurs or existing complaints worsen,
• a dangerous misjudgment occurs that delays medical help,
• or a potential danger to other persons arises.

Such incidents must be reported and investigated in accordance with the legal requirements (EU Regulation 2017/745, MDR) in order to continuously improve the safety of our products.

This is how you report a serious incident:

Please inform us immediately if you suspect such an event. You can reach us as follows:

📧 E-mail: kontakt@coreway.de

📞 Telephone (weekdays): +49 (0) 151 55448571

We ask you to describe the incident as precisely as possible and – if possible – to provide details of the date, time, symptoms and the information entered. All information will be treated confidentially and used exclusively for quality assurance and to comply with legal requirements.

The CorewayInsights app collects data entered by the patient on dietary habits and assessments of well-being and compares them individually with the S3 guidelines for Crohn’s disease and ulcerative colitis.

CorewayInsights is an interactive software-based medical application for self-management of the chronic inflammatory bowel diseases Crohn’s disease (ICD-10-GM: K50) and ulcerative colitis (ICD-10-GM: K51). 

CorewayInsights is intended for self-use by laypersons aged 18 and over. No medical training or specialist knowledge is required.  CorewayInsights does not replace medical treatment for Crohn’s disease and ulcerative colitis.

CAUTION: Please note the contraindications

Only use CorewayInsights if none of these contraindications are present.

CorewayInsights must not be used by: 

Missing medical diagnosis of IBD

Do not use CorewayInsights if you have not received a confirmed diagnosis of inflammatory bowel disease from your doctor.

Other chronic intestinal diseases

Do not use CorewayInsights if you are affected by another chronic bowel disease such as irritable bowel syndrome (IBS), diverticulitis or another gastrointestinal disorder.

Acute severe attack of illness

Do not use CorewayInsights if you are experiencing an acutely severe episode of illness that requires immediate medical intervention such as hospitalization.

Other health restrictions

Do not use CorewayInsights if you are not allowed to implement the recommended measures for medical reasons. This includes, for example, dietary restrictions due to other illnesses such as renal insufficiency or diabetes.

CorewayInsights is a software-based medical product that can be used in the form of a mobile application for Android and iOS smartphones with access to the App Store or Play Store. CorewayInsights is compatible with Android devices with software version Pie (version 9 and upwards). CorewayInsights is compatible with iOS devices (iPhone, iPad) with software version iOS 14.0 and higher. An internet connection (mobile data or WLAN) and a storage space of at least 100 MB are recommended to use the application. Additional devices are not required to use CorewayInsights.

CorewayInsights can be used in the following countries: 

• Germany
• Austria
• Switzerland
• Italy
• Belgium
• Netherlands
• Denmark

No. CorewayInsights is intended for non-professional use and does not require any medical expertise. A user must be able to operate a smartphone. No training or education is required to use CorewayInsights. To use CorewayInsights, however, you should be able to speak German or English (level B2) and have knowledge of how to use a smartphone.

CorewayInsights is a digital medical device that is based on

can be downloaded as an application on the smartphone. To start using the app, you need to register once at the beginning.

No technical or medical expertise is required for registration. It can be carried out by laypersons. The following is mandatory:

• E-mail address of the registrant

The recommended period of use is at least 12 weeks. However, the software is designed for safe use for at least 12 months, provided that available updates are installed regularly.

1. Download CorewayInsight from your App Store (Apple) or Google Playstore (Android) and open the app. 
2. Select the „Register“ option.
3. Enter your e-mail address, your name and a password. 
   Note: Make sure that the password contains at least 8 characters, upper and lower case letters and a special character.
4. Click on Register. 
5. A 6-digit code will then be sent to the e-mail address you provided. This is to verify your account. Confirm your e-mail within xx minutes to continue with the registration. 
6. Note: Please also check your spam folder. If you have not received an email, please contactsupport@core-way.de . If the verification code has already expired, click on the text „try again“.
7. Once you have successfully verified your e-mail address, you will be redirected to answer some general questions.
8. Indicate how old you are and which gender you identify with. 
9. Select what type of IBD you have been diagnosed with and whether you have a stoma. 
10. Select all the symptoms that you typically experience during a relapse. 
11. If you already know your personal thrust triggers, select these as well. If you don’t know what triggers your relapse, select the option „I don’t know my relapse triggers“.
12. Indicate whether you regularly take medication or are affected by other chronic illnesses. If this is the case, select all medications or other illnesses.
13. Specify whether you want to record your heart rate variability (HRV). 
    Note: A wearable (e.g. smartwatch, chest strap or smart ring) is mandatory for this. 
14. Agree to the privacy policy, the terms of use, the declaration of consent to the processing of your health data and the non-disclosure agreement. 
15. Once you have successfully registered, you will be taken to the CorewayInsights homepage.
16. Start using CorewayInsights.

Once you have successfully registered, you will land directly on the dashboard, your central starting point for all the app’s functions. Before you delve deeper into all the functions of the app, we recommend that you carry out an initial check-in.

Your first check-in

Start with an initial check-in to:

• Document your current condition and symptoms.
• Enter important health data for subsequent analysis.
• To create a basis for personalized recommendations.

General navigation in the dashboard

From here you can navigate through the entire app:

• Profile: Manage personal data and settings.
• Knowledge articles: Information and tips on CED.
• Daily check-in: Record your current state of health.
• Recommendations: Recognize patterns and get suitable tips.

If you are not on the dashboard, you can access it at any time via the home button.

Further steps

Make regular entries to obtain meaningful analyses and individual recommendations.

Consejo: Activate notifications so that you don’t forget anything and are reminded of your check-ins. 

You have the option of linking your wearable to the Terra API within the CorewayInsights app to automatically read out your heart rate variability (HRV). This eliminates the need for manual input.

To link your wearable, proceed as follows: 

1. After successful registration, a pop-up window appears with the option „Link wearable“.
2. Click on the button – a browser window will open.
3. Follow Terra’s instructions to establish the connection.
4. After completion, you will be automatically redirected back to the app. Your wearable is successfully linked to the app.

If you want to change or remove the link, you can do so at any time in the profile settings under „Wearable“

The CorewayInsights app offers you various functions and content.

Cuadro de mandos

The dashboard is your central starting point in CorewayInsights and offers you a quick overview of all components. You can go directly to the check-in, where you can record your current condition. You can also access your bowel movement and nutrition logs from here, manage your IBD history and call up individual analyses and recommendations. You can also access knowledge articles with helpful information via the navigation bar.

Daily check-in 

You can access the daily check-in via the plus symbol in the navigation bar or the check-in tile in the dashboard. Here you can document your current condition, important lifestyle factors and all disease-related information on a daily basis.

Medical questionnaire (Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index)

You can access the medical questionnaire directly via the corresponding tile in the dashboard. If you indicate in the check-in that you currently have symptoms, the questionnaire will open automatically within the process. It adapts individually to your form of IBD and contains standardized questions that help to assess whether you are currently experiencing a flare or not.

Stool log

In the stool log, you can record all your bowel movements on a daily basis and document important information about them at the same time.

IBD medical history

You can access your IBD medical history via the corresponding tile in the dashboard. Here you can store detailed information about your condition. If you want to make changes later, you can edit your medical history at any time in the settings on your profile page.

Data access

In the data view, you can call up all the information that you have documented in the check-in. The calendar in the dashboard takes you directly to your entries. Click on the desired date or use the monthly view to see older entries. If you want to add a check-in later, you can do this up to three days retrospectively. Simply select the relevant date and click on „Add check-in“.

Recommendations

You can access your personalized recommendations via the dashboard. Up to three recommendations based on your personal data are displayed here at weekly intervals. Once you have implemented a recommendation, you can mark it as completed and rate whether it was helpful for you. The recommendations are displayed as soon as you have used the check-ins for at least 7 days.

Tendencias

You can view trends in your health data by clicking on the corresponding tile in the dashboard. Simply click on ‘View data’ to get a detailed overview of the history of your documented data, such as symptoms or lifestyle factors. In addition, you can read summaries, compare different factors and access further information on selected aspects.

Knowledge contributions

You can access the knowledge articles via the navigation bar. There you will find a variety of blog posts on the topics of everyday life with IBD, nutrition and gut health, knowledge and research as well as experiences and community. If you want to (re)read a post later, you can save it with the bookmark. You can then find saved posts in the „Saved“ tab.

Profile

You can access your profile via the navigation bar. Here you can manage various settings, including general and medical data, shortcuts and notifications. You also have the option of logging out or deleting your account. 

NOTE: Removal of Data

When you delete your account, all your data will be irrevocably removed.

Support area

You can find the support area in the navigation bar. There you will find a FAQ section with answers to frequently asked questions. If you have any further questions or suggestions, you can contact us via the „Contact“ tab. Simply click on „Contact“ and your e-mail program will open automatically. You will also find all legal documents in the contact area, including the privacy policy, terms of use, consent to the processing of health data and the non-disclosure agreement.

To support the safe and effective use of CorewayInsights, notes, information messages y error messages are displayed in the form of small color-coded boxes within the user interface. These boxes appear depending on the context – e.. if entries are missing, a technical problem occurs or a specific function explanation is required.

The app also uses push-up notifications to draw your attention to important topics and functions when you are not using the app. These include, for example:

• Reminders for data collection
• Information on new content or functions
• Recommendations based on your previous information

You can set whether or not you want to receive notifications in the profile area at any time.

CorewayInsights is an interactive digital health application that combines the latest insights from gastroenterology and data science to ensure a holistic, evidence-based and personalized application for IBD patients.

Evidence-based means that our content is in line with the guidelines, i.e. based on the

are based on the latest scientific findings and medical recommendations.

Our team ensures that the content is kept up to date.

Holistic means that aspects from different areas, including nutrition and mental health, for example, are addressed.

Personalized means that the program is tailored to your individual needs.

is aligned. A friend who also uses CorewayInsights can therefore

may see different content than you do.

Using specially designed and validated questionnaires, you record your data in the app on a daily basis. This data is integrated into an algorithm that calculates which recommendations are provided to you.

Your details will be clarified by answering evidence-based medical questionnaires. These are particularly important as soon as you experience symptoms. These are the Harvey-Bradshaw Index for Crohn’s disease and the Simple Clinical Colitis Activity Index for ulcerative colitis. 

You can also fill in the IBD medical history so that the algorithm can evaluate your data in a more individualized way. Questions include how long an episode usually lasts for you. After you have initially completed the medical history, you will be asked every 3 months whether your details are still up to date. 

In the daily check-in, you indicate how severe your subjective symptoms are at the moment and whether you are currently experiencing a flare-up. Depending on the result, your recommendations for action are adapted to your needs. 

In general, you can receive recommendations from the following categories: 

• Psychosomatics
• Psychotherapy
• Pain management
• Alternative therapies
• Preventive medical check-ups
• Fatiga
• Symptom burden
• Nutrition

All content is taught to you in the form of self-help measures. This means that you implement the recommendations on your own. Once you have done this, you can tick the recommendation off as completed and assess whether it was helpful for you. 

By completing the daily check-in, you will also receive an assessment of your current well-being in the form of the so-called wellness score. This helps you to better assess your IBD.

NOTE: Third Party Access

Never let others access your CorewayInsights app account.

Recommended frequency and duration of use:

Unless you have received medical advice to the contrary, CorewayInsights is best used daily. You can use CorewayInsights for an unlimited period of time. The recommended time frame is at least 12 weeks.

The daily check-in serves to record your current state of health in a standardized way. Among other things, you document your general well-being, symptoms or other information relevant to IBD as well as lifestyle factors. The information is incorporated into the personalized data display and helps you to recognize patterns and identify links between lifestyle and disease.

We recommend performing the check-in once a day. You can start the check-in via the dashboard or the „+“ symbol in the navigation bar. 

In addition to the check-in, you will be asked to complete standardized medical questionnaires, depending on the information you provide. These are used to assess your current disease activity.

The following validated instruments are used:

• Harvey-Bradshaw Index (HBI) in Crohn’s disease
• Índice clínico simple de actividad de la colitis (SCCAI) for ulcerative colitis

These questionnaires are automatically displayed when you enter symptoms in the check-in. They help to assess whether you are experiencing a relapse and serve as a basis for targeted recommendations. You can also access the questionnaires via the dashboard or the „+“ symbol and can also complete them at any time if you are not currently experiencing symptoms.

The calendar component in the dashboard provides you with a chronological display of your previous entries. You can view past check-ins, stool and nutrition logs as well as your medical questionnaire results.

The data is displayed in a calendar. The monthly view allows you to conveniently select and analyze specific time periods.

Basierend auf deinen Angaben erhältst du individuelle Handlungsempfehlungen. Diese orientieren sich an aktuellen S3-Leitlinien für die Behandlung von Morbus Crohn Based on the information you provide, you will receive individual recommendations for action. These are based on current S3 guidelines for the treatment of Crohn’s disease and ulcerative colitis. 

You can receive recommendations from various categories: 

• Psychosomatics
• Psychotherapy
• Pain management
• Alternative therapies
• Preventive medical check-ups
• Tiredness
• Symptom burden
• Nutrition

All recommendations are to be understood as non-medical self-help recommendations and do not replace medical treatment. 

As soon as you have implemented a recommendation, you can mark it as completed and rate whether the recommendation was helpful for you.

7.5. Stool Protocol

In the stool log, you can record the frequency, consistency and accompanying symptoms of your bowel movements. You can also note any blood, mucus or urgency. This data provides important information about the current level of inflammation and helps you keep track of your current disease activity. The log is based on established classifications from the Bristol Stool Scale. Entries should be made after each bowel movement or summarised at least once a day.

7.6. IBD-Anamnesis

The IBD medical history will be displayed in the dashboard once you have completed it. Here you can add additional information about your IBD so that the CorewayInsights app can provide you with even more personalised support.

7.6. Trends

The trends offer you a personalised overview of your health development. You can visually compare the progression of symptoms and lifestyle factors over time and view various data entries in graphical form.

In addition, you will receive a summary of the data displayed and can access further helpful knowledge articles relevant to the respective display.

In addition to the core functions, CorewayInsights offers additional content to support your self-management:

Knowledge contributions

Within the app you will find scientifically based articles on the following categories: 

• Everyday life with CED
• CED nutrition and gut health
• CED knowledge and research
• CED experiences and community

Preguntas frecuentes

You can find out all about coreway, our study and the app in the app’s FAQs. 

Reminder function

Push notifications are available for check-in reminders, new recommendations and important changes.

You can access this content via the menu within the app. 

To remove CorewayInsights, the account must be deleted and the

application can be uninstalled. To delete your account, open the profile settings and select „Delete account“. Your user data will then be deleted in accordance with the privacy policy.

You can then uninstall the application.

The account and user data will also be deleted in accordance with the privacy policy if an account is inactive for more than 5 years.

The CorewayInsights software was developed and evaluated in accordance with the following standards:

Standard	Title
DIN EN ISO 13485	Medical devices – Quality management systems – Requirements for regulatory purposes
DIN EN ISO 14971	Medical devices – Application of risk management to medical devices
ISO/IEC 27001	Information security, cyber security and data protection – Information security management systems – Requirements
DIN EN ISO 20417	Medical devices – Requirements for information to be provided by the manufacturer
DIN EN ISO 15223-1	Medical devices – Symbols to be used on medical device labels, labeling and information to be supplied – Part 1: General requirements
DIN EN ISO 7010	Graphic symbols – Safety colors and safety signs – Registered safety signs
DIN EN ISO/IEC 82079-1	Preparation of instructions for use of products – Part 1: Principles and general requirements
DIN EN 62366-1	Medical devices – Part 1: Application of fitness for purpose to medical devices
DIN EN 62304	Medical device software – Software lifecycle processes
DIN EN 82304-1	Healthcare software – Part 1: General requirements for product safety
CEI 81001-5-1	Health software and health IT systems Safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle

The CorewayInsights app has been developed and tested with the utmost care. It complies with the applicable legal requirements of the European Union for medical devices (Class I according to Regulation (EU) 2017/745).

Warranty

The manufacturer guarantees that the app is free of technical defects that significantly impair its functionality at the time of provision.

Please note:

• The warranty only applies if the device is used properly in accordance with these instructions for use.
• Modifications to the device on which the app is operated and improper use may impair its functionality and lead to the exclusion of the warranty.

Disclaimer

The use of the app does not replace medical advice, diagnosis or treatment. The manufacturer is not liable for damage caused by incorrect or incomplete information provided by the user, misuse or disregard of these instructions.

Liability for indirect damage (e.. consequential damage, loss of data) is excluded unless liability is mandatory by law (e.. in the case of intent or gross negligence).

If you have any questions about the contents of these instructions for use or the use of the

product, please contact us as the manufacturer.

Contact details of the manufacturer:

If you have any questions about CorewayInsights or need help with the application, please contact us at kontakt@core-way.de
If you have detected a technical error, please contact us immediately at support@core-way.de. 

Manufacturer address

CorewayInsights 
By coreway UG (limited liability)
Bischof-Keppler-Straße 9
73525 Schwäbisch Gmünd

If you notice any changes to your health that may be related to the use of CorewayInsights, please contact us immediately.

If you need a paper version of these instructions for use, please contact us.

CorewayInsights is registered in the European Union as an active medical device of the Class I registered according to the Medical Device Regulation 2017/745/EU.

Abbreviation	Meaning
MDR	Reglamento sobre productos sanitarios (UE) 2017/745
CED	Chronic inflammatory bowel disease
GDPR	General Data Protection Regulation
UE	European Union
UDI	Identificador único de dispositivo
INTERFAZ DE USUARIO	User interface

Glossary

Users

Natural person who uses the medical device as intended.

Chronic inflammatory bowel disease (IBD)

Generic term for diseases such as Crohn’s disease and ulcerative colitis, which are characterized by inflammatory processes in the gastrointestinal tract.

Instructions for use

Accompanying document of a medical device with information on safe and appropriate use in accordance with MDR Annex I.

Clinical benefit

Measurable positive effect of a medical device on the patient’s state of health.

Verification and validation (V&V)

Methods for checking (verification) whether requirements have been implemented correctly and for confirming (validation) that the product is suitable for the intended purpose.

Identificación única de dispositivos (UDI)

Clear product labeling for traceability of medical devices in accordance with MDR Article 27.