CNCps - Centro Nacional de Certificación de Productos ...

CNCps - Centro Nacional de Certificación de Productos Sanitarios (National Certification Center for Medical Devices)

User Manual

Version 1.0.3

Spanish Agency of Medicines and Medical Devices

Fecha de publicación: 01 de junio de 2021 División de Sistemas de la Información

Centro Nacional de Certificación de Productos Sanitarios. Solicitud de marcado CE / Certificación ISO 13485

Guía de apoyo al solicitante para la correcta cumplimentación y gestión informática de solicitudes

Sede electrónica de la Agencia Española de Medicamentos y Productos Sanitarios

Index

1. INTRODUCTION ..................................................................................................................................... 3

2. APPLICATION LOGIN ............................................................................................................................. 3

2.1. Access Requirements ............................................................................................................................... 3

2.2. CNCps Log-In ............................................................................................................................................ 4

3. STARTING A DRAFT APPLICATION.......................................................................................................... 6

3.1. Step 1. Selecting the type of procedure .................................................................................................... 6

3.2. Step 2. Selecting the applicant ................................................................................................................. 6

3.3. Step 3. Data ............................................................................................................................................. 8

4. UPLOADING DOCUMENTATION USING THE TABS ............................................................................... 10

4.1. TAB: Datos Generales (General Data) ..................................................................................................... 10

4.2. TAB: Ficheros Adjuntos (Attached files) .................................................................................................. 11

4.3. TAB: Pago de tasas (Payment of fees) ..................................................................................................... 18

5. TAB: ACCIONES (Actions) .................................................................................................................... 23

5.1. SECTION: Realizar acción (Perform action) ............................................................................................. 24

5.2. SECTION: Acciones realizadas (Actions performed) ................................................................................. 26

5.3. SECTION: Oficios (Official documents) ................................................................................................... 26

5.4. SECTION: Correos enviados (Sent mail) ................................................................................................... 26

6. APPLICATION CONSULTATION ............................................................................................................. 27

6.1. Search .................................................................................................................................................... 27

7. SUPPORT / ERROR NOTIFICATION ....................................................................................................... 29

8. REFERENCES........................................................................................................................................ 29

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Centro Nacional de Certificación de Productos Sanitarios. Solicitud de marcado CE / Certificación ISO 13485



MINISTERIO DE SANIDAD

Agencia Española de

Medicamentos y Productos

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1. INTRODUCTION

The Spanish Agency of Medicines and Medical Devices (AEMPS) has adopted an initiative for companies to carry out the procedures related to the CE marking and he ISO 13485 standard certification through the web application CNCps – National Certification Center for Medical Devices.

2. APPLICATION LOGIN

2.1. Access Requirements

Every user who wishes to access the application has to be registered as an authorized user in CNCps. If the company already has access to any of the AEMPS applications, the applicant will already have access to CNCps.

If you are not already registered, you must request access through the following link: Portal de peticiones AEMPS - Service Desk

You must click on Gestión de Accesos Solicitud de acceso.

You have to provide the following information in order to complete the user registration for the application:

User Information:o Nombre (Name) o Apellidos (Surname) o NIF (In the case of foreigners, a tax identification code is required) o Pais (Country) o Correo electrónico (E-mail) o Perfil de usuario (User profile)

1. Solicitante (Applicant) 2. Solicitante contabilidad (sólo tendrá acceso al pago de tasas)

• Data of the entity, or entities, with which it has to be associated

o Nombre (Name) o CIF (In the case of foreigners, the VAT (European) or the tax identification code is

required)

o País (Country)

https://servicedesk.aemps.es/servicedesk/customer/portal/2

https://servicedesk.aemps.es/servicedesk/customer/portal/2

Centro Nacional de Certificación de Productos Sanitarios - Solicitud de marcado CE / Certificación ISO 13485






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Once the necessary information have been provided, the registration will be managed by the AEMPS so that you can access the application as soon as possible. To be registered to the AEMPS Service Desk will enable you to request the credentials to access CNCps, and later to be able to send any incident or query regarding the application.

2.2. CNCps Log-In

The CNCps application is available through the following link: https://sinaem.agemed.es/CNCps/Login.aspx or from the Sede Electrónica: https://www.aemps.gob.es/

To log into the application please provide your usuario (User Name) and contraseña (Password).

https://sinaem.agemed.es/CNCps/Login.aspx

http://www.aemps.gob.es/







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IMPORTANT: If you have your Username, but do not remember your password. You can reset your the password by clicking on the “Restablecer contraseña” button.

https://pfirma-info.aemps.es/pfirma/restablecerPassword/peticion







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3. STARTING A DRAFT APPLICATION

3.1. Step 1. Selecting the type of procedure

La creación de solicitudes sólo está disponible para el perfil “Solicitante”. El perfil “Solicitante Contabilidad” no tiene acceso a esta funcionalidad.

To start an application, you must choose between the different procedures set out in STEP 1 (point 1). Once the procedure has been selected, click on the blue “Procedimiento seleccionado” (Selected Procedure) button to confirm.

Once the type of procedure has been confirmed, a pop-up will appear in which you must select the type of application from a drop-down menu. The selection can be confirmed by clicking on the blue "ACEPTAR" (Accept) button.

It is important that the correct procedure and type of application that has been selected is appropriate, because the documents that need to be uploaded and the payment of fees will depend on the selection.

3.2. Step 2. Selecting the applicant







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Next, a screen will appear where you have to select the company. If the validated user is only related to one company, this company will be selected automatically. If the user is related to several companies a search engine will appear to filter and select the corresponding company.







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3.3. Step 3. Data

This part of the form consists of three sections that need to be completed:

DATA OF THE HOLDER (Data of the applicant company)

APPLICANT (Data of the person responsible for the application or the contact person, who will

receive the notifications regarding the application)

APPLICATION DETAILS. Depending on the type of application, the data may vary from one type of application to another. You must fill in all of the fields that are marked as mandatory. In the event that you are creating an application that is associated with a new product, you must complete the “Nombre de producto/Expediente técnico” (Product name/technical file) field, with a maximum length of 75 characters. We recommended to pay special attention at this point since the information entered in this field becomes identification reference of the product, which will accompany it throughout the certification life.







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In the event that the created application must be associated with an existing product (e.g. modifications), when writing in the field indicated above, the system will offer the names of the products that match the text that the user is entering. You must select one of the existing products.

In the case of applications relating to the CE marking, the fields “Tipo de producto sanitario” (Type of medical device) and “Clasificación” (Classification) must be completed by choosing one of the options offered by the drop-down menu. For the fields of NANDO MDD/IVDD, NANDO MDR/IVDR, genérico (generic) and Tipo Producto (Product Type) you must select between one of the options offered by the blue "Filter" button that appears in the pop-up.

In the case of applications relating to the certification of ISO 13485, the fields of “Áreas tecnológicas 13485” (Technological areas 13485) and “Áreas tecnológicas 13485. Detalle” (Technological areas 13485. Details) must be completed by selecting from one of the options offered by the blue "Filter" button that appears in the pop-up.

Once the sections have been completed, do not forget to click on “Guardar y continuar” (Save and continue) button, to save the information provided and create the application in the system.







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4. UPLOADING DOCUMENTATION USING THE TABS

Once the application form has been completed, you can proceed to upload the required documentation. To upload the documents, we will navigate through the following tabs that appear at the top of the webpage.

El perfil “Solicitante” tiene acceso a todas las pestañas que se describen a continuación. El perfil “Solicitante Contabilidad”, únicamente tendrá acceso a la pestaña de PAGO DE TASAS.

4.1. TAB: Datos Generales (General Data)

In this tab, you will find the initial data related to the application. These values should be reviewed, and if needed modified before finalizing the application.

You have to fill in all the required fields. When you finish making these changes, you have to press “Guardar cambios” (Save changes) button, so the changes are saved properly.







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IMPORTANT: In this section, you can attach multiple files of different types with a maximum size of 10MB per file

4.2. TAB: Ficheros Adjuntos (Attached files)

In this tab, the necessary documentation for the processing of the application will be loaded. This section is divided into several zones.

There are certain files that are mandatory for sending the application. When sending the application, the attached files are checked and if any of the required files are missing, the corresponding message will appear and the application will not be sent.

4.2.1. FORMS

Forms related to the type of application being made should be included.

In “Plantilla tipo documento” (Document template type) column, the template of the form can be download through the link “Descargar plantilla” (Download template). In “Adjuntar/ver documento” (Attach/view document) column, we can add as many documents of the same category as necessary (i.e. as many 93-42-2 forms as supplementary premises to be audited) or download a previously uploaded document by clicking on “Descargar documento” (Download document). While the application is still a draft, you can delete the uploaded documents by clicking on the “X” icon in the last column.

4.2.2. DOCUMENTATION TO BE ATTACHED

In addition to the forms, there are also other categories of complementary documentation to be attached. You can upload these documents in this section.







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IMPORTANT: In this section, you can attach multiple files of different types with a maximum size of 10MB per file

The process is very similar to that of the FORMS section. The different categories of documents are shown, and you have to click on the “Adjuntar documento” (Attach document) link in the “Adjuntar/ver documento” (Attach/view document) column.

While the application is still a draft, you can delete the uploaded documents by clicking on the “X” icon in the last column.

4.2.3. TECHNICAL FILE

This section will only be visible if the type of application requires an “EXPEDIENTE TÉCNICO” (TECHNICAL FILE) to be provided.

To upload the technical documentation, you have to click on “Acceder al módulo” (Access the module) in the column “Acceso a documentación de Expediente Técnico” (Access to technical file documentation) that will take us to the next screen:

The “Expediente Técnico” (Technical File) submissions must meet certain requirements in order to be accepted. The requirements are detailed below:







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Please, name the files included in the Technical File as short as possible (como se ha indicado, con un máximo de 25 caracteres), to minimize the risk of erroneous or incomplete copies.

If you have selected “Producto Sanitario” (Medical Device) the folder structure should be the following:

If you have selected “Producto Sanitario de diagnóstico In Vitro” (In Vitro Diagnostic Medical

Device) the folder structure should be following:

In either case, you can always download a structure that has already been created from the information box that appears on the screen.

Within the folders that must be included in the submission (structure indicated above), any content can be included, i.e., compressed files, files with any extension, nested folders, etc. Always complying with the aforementioned size restriction. Sólo estará permitido un único nivel de anidamiento de carpetas dentro de las carpetas “fijas”. Todos los nombres tanto de ficheros como de carpetas que estén dentro de las carpetas “fijas”, deben tener un máximo de 25 caracteres.

The folder structure must be included in a compressed file, with ".zip" extension.

The allowed extensions are those generated by the WinZip compressor:

Example: TF_test.z01, TF_test.z02, TF_test.z03… TF_test.zip







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If the type of application is not linked to a specific product when the Technical File documentation is added, then the name of the Technical File to which the documentation is to be linked must be indicated.

As it was done in the creation of the application, as the characters are typed, the system will offer the names of technical files that match the text. If you are typing a name that does not exist, the new Technical File will be created automatically. Once all the corresponding files have been provided, you must click on “Cerrar envío Expediente Técnico” (Close technical file submission) button, before submitting the application. If, once closed, you detect that there is an incorrect file, or it is necessary to include more files, you can reopen the submission by clicking “Abrir envío” (Open submission) button.

If the zip folder created from the compression exceeds the indicated 10MB, you can divide the content into several 10 MB folders.







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IMPORTANT: In this section, you can attach multiple files of different types with a maximum size of 10MB per file.

4.2.4. CORRECTIVE ACTION AFTER AN AUDIT

In order to correct the findings detected during the audit, the application will enable the section there “ACCIONES CORRECTIVAS” (CORRECTIVE ACTIONS)

This section will only be visible in the event that an audit requires additional documentation to be attached for its resolution.

To do so, click on “Acceder al módulo” (Access the module) link, in the section “Acceso a acciones correctivas” (Access to corrective actions).

In the corrective actions page, several kind of information can be uploaded:







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It is mandatory that at least one file of the type “Modelo 93-42-15: Acciones Correctivas” (Model 93-42-15: Corrective Actions) is attached.

The inclusion of a "Technical File" in the corrective actions is also allowed, with the same size limitations already indicated in the "TECHNICAL FILE" section.

If the type of application is not linked to a specific product when the Technical File documentation is added, then the name of the Technical File to which the documentation is to be linked must be indicated.

As it was done in the creation of the application, as the characters are typed, the system will offer the names of technical files that match the text. If you are typing a name that does not exist, the new Technical File will be created automatically.

Once all the documents corresponding to the Corrective Action have been entered, the submission must be closed by clicking on the “Cerrar envío Acciones Correctivas” (Close Send Corrective Actions) button. If you want to include new documents in a closed shipment, you will have to click on “Abrir envío Acciones Correctivas” (Open Corrective Actions) button.







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The documentation entered in the corrective actions will be sent when the action of “SUBSANACIÓN DE DEFICIENCIAS / ACCIONES CORRECTIVAS” (CORRECTION OF DEFICIENCIES / CORRECTIVE ACTIONS) is performed.







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4.3. TAB: Pago de tasas (Payment of fees)

Esta es la única pestaña disponible para el perfil de “Solicitante Contabilidad”.

From this tab, the fee payments for the selected type of application will be made.

In order to register the application with the AEMPS, it is necessary that proof of fee payments are included. The boxes that indicate the applicable taxes will appear disabled for the applicant as they are mandatory for the procedure. They cannot be unchecked. By default, they will be showing 1 unit (although more units can be added). In subsequent payments of fees within the application (if necessary), additional fee boxes will be enabled so they can be marked and the required number of units can be entered.

By clicking on “Realizar el Pago” (Make Payment) button we access to the fee payment platform.

A screen will appear with a warning that you are being redirected to the fee payment platform. In some cases, you might not be redirected automatically, and you have to press the “ACCEDER PLATAFORMA DE PAGOS” (ACCESS PAYMENT PLATFORM) button.

Once you have accessed the fee payment platform, you will have to check that all the data that has been automatically transferred is correct.







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Once the payment has been made a summary with the “número de justificante” (receipt number) appears.







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IMPORTANT: You have to click on “Volver” (BACK) button, to return to the fee payment platform.

Then, after returning to the fee payment application, the relevant data of the payment will be displayed.

If more payments need to be made, you can repeat the steps mentioned above.







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IMPORTANT: Once the payment has been made, it may take up to 24-48 hours for the payment to be finalized in the AEMPS systems. A notice will appear indicating this circumstance.

Debido a esta circunstancia, en la pantalla sólo se visualizarán por parte del usuario los pagos que ya hayan sido “conciliados”, esto es, la AEMPS ya haya recibido del banco la confirmación de pago. En caso de que aún no se haya producido esta “conciliación”, aparecerá el siguiente mensaje:

Si aparece este mensaje y el pago ha sido realizado correctamente por el Solicitante NO HAY QUE VOLVER A ACCEDER A LA PASARELA DE TASAS PARA REALIZAR UN NUEVO PAGO

Si el solicitante intenta realizar un nuevo pago (si el primer pago, pese a haberse generado el justificante, no ha llegado a completarse), le aparecerá un mensaje de confirmación.

Habrá que pulsar el botón de “Aceptar” para acceder a la plataforma de tasas.

Once the payment has been made in the AEMPS, the registration of the application will be completed.

If you have any incident in the payment process, you must create a ticket via Jira. You can find the link for Jira in the footer of the home screen of the fee payment application.

https://servicedesk.aemps.es/servicedesk/customer/portal/2/user/login?destination=portal%2F2

https://servicedesk.aemps.es/servicedesk/customer/portal/2/user/login?destination=portal%2F2







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5. TAB: ACCIONES (Actions)

Once the application documentation has been attached, and the corresponding fees have been paid, you have to go to the “ACCIONES” (ACTIONS) tab. In this tab, we can find four sections:

1. “REALIZAR ACCIÓN” (PERFORM ACTION)

2. “ACCIONES REALIZADAS” (ACTIONS PERFORMED)

3. “OFICIOS” (OFFICIAL DOCUMENTS)

4. “CORREOS ENVIADOS” (E-MAILS SENT)







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IMPORTANT: The first time you submit your application to the AEMPS, the system will review the documents attached to the application. If the mandatory documents are not attached to the application, you will not be able to continue, and the corresponding notice will be displayed for you to correct.

5.1. SECTION: Realizar acción (Perform action)

In this section, we can perform different actions that will change depending on the status of the application and the type of application.

Sometimes, it takes up to 24-48 hours for the payment to be finalized in the AEMPS systems. If this circumstance is detected when sending the application, the following notice will appear:







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At this point, the application has been sent correctly. However, the application will remain in a blocked state until the payment has been finalized. Once the payment has been finalized, the application will be unlocked automatically and you will be able to continue with the flow of the application.

5.1.1. ACEPTACIÓN DE PLAZOS (ACCEPTANCE OF DEADLINES)

If applications require a deadline, a tab with options will appear so that the applicant can accept the proposed deadlines, request an extension of the same, or withdraw the application by proposing and justifying new dates.







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5.2. SECTION: Acciones realizadas (Actions performed)

This section will show the history of actions between the applicant and the CNCps that have been carried out throughout the process of the application.

5.3. SECTION: Oficios (Official documents)

This section shows the history of documents sent/received in the process of the application. You also have the possibility to forward a document.

5.4. SECTION: Correos enviados (Mail sent)

This section displays a list of automatic e-mails that the application has sent throughout the different steps of the application process.







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6. APPLICATION CONSULTATION

6.1. Search

In this section, you can search for applications associated with the user with whom you are authorized. There are different search criteria, to be able to narrow down the results.

In the search results, an icon may appear in some applications.

Hovering over these icons with the mouse it will bring up the relevant information regarding deadlines and actions.







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To access the details of the request, you must click on the lens icon that appears at the end of each row.







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7. SUPPORT / ERROR NOTIFICATION

APPLICATION

If you experience any error or difficulties during the application process, please let us know by submitting a service ticket through the following link:

https://servicedesk.aemps.es/servicedesk/customer/portal/2/ (aplicación “CNCps”)

Please include as much information as possible about the incident, including screenshots, error messages, etc. to make it easier for our technicians to detect and resolve the problem.

FEES

For questions related to fees, if you experience any error or difficulties regarding the payment of fees, please let us know by submitting a service ticket through the following link:

https://servicedesk.aemps.es/servicedesk/customer/portal/2/ (Incidencias –Aplicación TASAS)

USE

For questions related to the logic or use of the application, please contact us at:

[email protected]

8. REFERENCES

Information and conditions for CE marking (https://www.aemps.gob.es/productosSanitarios/organismoNotificado/docs/ce_informacion_y_ condiciones.pdf)

Notified Body 0318 and Certification 13485 (https://www.aemps.gob.es/productosSanitarios/organismoNotificado/home.htm)

European Commission/Internal Market, Industry, Entrepreneurship and SMEs/The European single market/CE marking (https://ec.europa.eu/growth/single-market/ce-marking_en

mailto:[email protected]

https://www.aemps.gob.es/productosSanitarios/organismoNotificado/docs/ce_informacion_y_condiciones.pdf



https://www.aemps.gob.es/productosSanitarios/organismoNotificado/home.htm

https://ec.europa.eu/growth/single-market/ce-marking_en

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