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Xatena AG, Stockerstrasse 33, CH-8002 Zürich/Switzerland Business Unit Data Services Tel. +41 44 577 57 31 / www.xatena.com

Collection of product data in connection with the implementation of European Union Medical Device regulation (MDR) on behalf of the Insel Gruppe AG / Bern, the cantonal hospitals Winterthur and Graubünden and the hospital center Biel (all Switzerland)

A. Manual to register on www.xatena.com

1. Login

1.1. Open https://www.xatena.com/prod/#/login in your internet browser (we recommend: Google Chrome, Mozilla Firefox or Microsoft Edge)

1.2. Personal login

• In case you already have a login: Use your login/password to log on the platform. If you don’t have your login information available, request a new password. After successful login, please go to section B of this manual.

• In case you don’t have a login: Go to the next point to create your profile and to get your login/password.

2. Register new company account & personal login1

(only available in german language on the platform, see translation below)

2.1. Click on «Unternehmen registrieren» (green button)

2.2. Enter company & personal information

Translation:

• Rolle = type: Manufacturer (Hersteller), Distributor (Händler), Service provider (Dienstleister)

• Firma: Company name

• Beschreibung: Scope of business

• Firmenlogo: Upload company logo

• Adresse/Domizil: Street/Nr./ ZIP-Code/City/ Country

• Telefon-Nr.: Phone number

• UID: Company ID (only for swiss companies)

1 If your company is already registered on Xatena, we will add your profile to your existing corporate account.

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Translation:

• Anrede: Mister (Herr), Mrs. (Frau)

• Vorname/Name: First name/last name

• Email: Scope of business

• Passwort: Select your own password • Anmeldemethoe: Login method (please select as

on picture) • Terms of use: Please confirm terms of use

2.3. After registration, your profile will be approved by Xatena within 24-48 hours. You will receive a

message via e-mail as soon as the approval is completed. 2.4. After receiving the approval e-mail you can log in with your access data.

B. Instructions for completing the template for the product data/information

1. Download XLS-Template

1.1. Login to the platform with your login data. 1.2. Open the catalog by using the button «Katalog öffnen»

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1.3. To download the template, click the button «Produkt-Import Excel».

1.4. Click on „Standard-Excel-Format MDR“ to download the template. Read the instructions in the tab

in english language.

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1.5. Open the template in Microsoft Excel. Please note that the template is protected, therefore the fields can not be changed. Saving the file is possible at any time.

1.6. Fill your product data in the "Import" worksheet. The description of the table columns can be found in the sheet «instructions english»

1.7. The description of the columns can be found in the "instructions" spreadsheet, please note the information about the individual fields. It is very important to follow these guidelines and to fill out the template as required, otherwise the data import can fail and needs to be repeated.

Category 1 Title in template Description mandatory/optionalGeneral product information cn:title Product-title, short mandatoryGeneral product information description Product description, detailed mandatoryGeneral product information supplier_article_nr Supplier product/order number mandatoryGeneral product information producer Name of manufacuter mandatoryGeneral product information producer_article_nr Product nummer of manufacturer mandatory

General product information attr_current_certification_baseCurrent regulatory base, which the product is certified

mandatory

General product information attr_risk_class_mdd Risk class MDD mandatory

General product information attr_risk_class_mdr Risk class MDR optional, if not available, please give an indicative date when MDR Risk classification is expected to be available

General product information attr_sterile Sterile packaging yes/no mandatoryGeneral product information attr_implant Implant yes/no optional, but expectedGeneral product information attr_singleuse Approved disposable product, yes/no optional, but expectedGeneral product information attr_gtin_a GTIN A (Single piece packaging) Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_quantity_gtin_a Number of pieces in packaging with GTIN A Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_gtin_b GTIN B (Multiple packing) Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_quantity_gtin_b Number of pieces in packaging with GTIN B Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_gtin_c GTIN C (Box) Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_quantity_gtin_c Number of pieces in packaging with GTIN C Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_gtin_d GTIN D (Pallet) Indication of GTIN (A,B,C or D) mandatoryGeneral product information attr_quantity_gtin_d Number of pieces in packaging with GTIN D Indication of GTIN (A,B,C or D) mandatory

Product information (to be entered in register "Import", for upload see instructions in manual)

General product information attr_in_use_at_insel Product in use at Insel Gruppe AG, if ordered since Jan 1, 2017, yes/no

optional, only relevant for suppliers of Insel Gruppe AG

General product information attr_serialnumbers_available Serial number available yes/no optional, but expectedGeneral product information attr_lotnumbers_available Lot Nr. available yes/no optional, but expected

General product information eclassidID eClass Classification (Version 10.1) for implementation into catalogue, allowed with and without "-"

optional

General product information picture_url Permanent link (URL) for product picture optional

mandatory

Certificates (Upload to platform see manual "Registration and data upload")

MDR relevant product information Certificate of conformity (on category level sufficient)

Upload of currently valid declaration of conformity (on category level sufficient) as pdf, for instructions see manual "Registration and data

mandatory

MDR relevant product information attr_certificate_expiry Expiration date of currently valid declaration of conformity

mandatory

MDR relevant product information attr_notified_body_number Notified body number: Number of notified body who issued to certificate

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1.8. Upload the complete Excel file with «Product-Import Excel». See instruction under section C of this manual.

1.9. Note: If product data needs to be to changed or added after the import has been done, we recommend to do the changes in the Excel-template and to re-import the Excel again.

C. Instructions for uploading product data and certificates at www.xatena.com

1. Upload product data

1.1. Login the platform using your username and password 1.2. You are now in the „Xatena-Cockpit 1.3. Open the catalog and click «Katalog öffnen» (open catalog)

Comment for category:

General product information

MDR relevant product information

General product information

Product information is part of the master data pool and will be available in the Xatena product catalog for all Xatena registered hospitals. The supplier has the

option to not publish his products in the catalog. In this case the products are not visible in the catalog and can not be searched for or viewed by the hospitals.

As a result, there is no automatic proposal of the supplier for procurement projects/RFx by hospitals.

Product information is part of the MDR data pool and can only be seen by those hospitals who have mandated Xatena to collect MDR-relevant data. There is

no publication in the Xatena product catalog.

Product information is part of the MDR data pool and can only be seen by those hospitals who have mandated Xatena to collect MDR-relevant data. There is

no publication in the Xatena product catalog.

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1.4. To upload product data please click on «Produkt-Import Excel»

1.5. Note: If you need to change or add data after the import has been done, we recommend to

change/add this in the Excel-template and to re-import the Excel-template. Already uploaded products will be updated automatically. In case there are already products on the platform that you have no longer included in the Excel-template, you’ll be asked in the next step what you would like to do with them. The first option automatically deletes these products and the second option keeps them on the platform.

1.6. Upload the complete Excel file with «Product-Import Excel». Select the file and choose your

preferred option what to do with existing products that are not uploaded anymore. As already mentioned, the first option deletes all existing products that are not uploaded anymore, and the second option keeps them on the platform. Then click on "Weiter" and then "Fertigstellen"

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1.7. With one click the uploaded product data will be listed in the classified product group.

Note: if a product has no “ecl@ass”-ID it will be classified under “interim classification”

2. Uploading certificates 2.1. Select the function „Firmenprofil anpassen“ (change company profile) in the cockpit.

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2.2. Upload all certificates under the section „Dokumente / Zertifikate“ at the bottom of the screen, using PDF or ZIP-format

Note: • The maximum size per file

is limited to 100 MB. • We recommend to upload

the certificates by using a „Zip-archive“.

3. Updating product data after upload If you wish to update existing products in the catalog, please select the function “Katalog aktualisieren” (update products in catalog). You have the following options. 3.1. Update more than one product

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A) Delete all products which have not been updated (“Nicht mehr hochgeladene Produkte löschen”) Existing products in the catalog will be deleted if not included in the update file. B) Keep products in the catalog which not have been updated (“Nicht mehr nochgeladene Produkte im

Katalog behalten”) Existing products in the catalog will NOT be deleted if not included in the update file. 3.2. Update a single product

3.2.1. Go to main menu on platform 3.2.2. Choose «Produktkatalog öffnen» (Open product catalog) 3.2.3. Select product to be updated/changed unter “Gesamtsortiment” 3.2.4. Select “edit mode” by clicking on icon on the bottom right of the product (mouse over) as seen in

red below

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3.2.5. Edit product data as required and save the changes. Then leave the product catalog.

Version: 5.12.19