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Provision of Mechanism for scrutiny

For the Product certificate type, higher risk devices, as defined by Article 55 (MDR) or Article 50 (IVDR), will require the provision of the Mechanism for scrutiny:

EUDAMED mechanism for scrutiny page

Case A: MDR devices

  1. The system will verify and display all CECP records registered for the Basic UDI-DI(s) in the scope of this certificate. By default, the Clinical Evaluation Assessment Report (CEAR) will display, which is viewable and downloadable:

    EUDAMED clinical evaluation assessment report document in mechanism for scrutiny page

    Case A.1: CECP status set to Opinion

    • Click Browse to upload the scientific opinion document:

      EUDAMED scientific opinion document field and browse button

    • Confirm if the scientific opinion is followed. If yes, click Yes and no further action is required. If no, click No and upload a justification document:

      EUDAMED is this scientific opinion followed and justification document fields

    • For each Basic UDI-DI, select the language(s) for the Instructions for use document(s). Each document may be in multiple languages, which display next to the file once uploaded:

      EUDAMED select the language for the instruction for use field and browse button

      Note

      The Browse button is activated only after the selection of at least one language from the menu. Otherwise, it is greyed out.

      You can upload multiple documents for a Basic UDI-DI.

    • Note that the confidentiality disclaimer needs to be marked as read in order to continue. Now click Save to save as a draft, Preview to verify the information provided, or Submit to submit your registration.

      EUDAMED agree to the disclaimer and save, preview, submit and cancel buttons

    Case A.2: CECP status set to No Opinion

    • For each Basic UDI-DI, select the language(s) for the Instructions for use document(s). Each document may be in multiple languages, which display next to the file once uploaded:

      EUDAMED select the language for the instruction for use field and browse button

      Note

      The Browse button is activated only after the selection of at least one language from the menu. Otherwise, it is greyed out.

      You can upload multiple documents for a Basic UDI-DI.

  2. Confirm the accuracy of the device data in the pop-up window:

    EUDAMED submit my request and cancel buttons

You will be shown a page confirming your registration:

EUDAMED confirmation message when submitting a certificate registration

From here you can click View the certificate you just created to view the certificate, or you can click the Go to homepage link in order to return to your homepage.

Case B: IVDR devices

  1. If the mechanism for scrutiny is done outside EUDAMED, set the toggle button to No and click the Browse button to upload the Performance evaluation assessment report:

    EUDAMED mechanism for scrutiny done outside eudamed toggle button and performance evaluation assessment report to upload

    Otherwise, set the toggle button to Yes and go to step 5:

    EUDAMED mechanism for scrutiny done outside eudamed toggle button set to yes

  2. Select Yes or No for the fields Laboratory tests and the scientific opinion by the EU reference laboratory (EURL) and Expert panels views applicable:

    EUDAMED toggle buttons and browse buttons to upload documents in the mechanism for scrutiny step

    Note

    If you select Yes, click the Browse button to upload the required documents. Otherwise, uploading a document is not required. Hence, the Browse button will not be visible.

  3. The field Divergent views between the NB and the expert panel? is visible if you set the toggle button to Yes in the Expert panels views applicable. Select Yes or No:

    EUDAMED divergent views between the nb and the expert panel field and browse button to upload a document

    Note

    If you select Yes, click the Browse button to upload the justification. Otherwise, uploading a document is not required. Hence, the Browse button will not be visible.

  4. For each Basic UDI-DI, select the language(s) for the instruction(s) for use. Each document may be in multiple languages, which display next to the file once uploaded:

    mechanism_for_scrutiny_ivdr_instruction_for_use.png

    Note

    The Browse button is activated only after the selection of at least one language from the menu. Otherwise, it is greyed out.

    You can upload multiple documents for a Basic UDI-DI.

  5. Click the Submit button.

You will be shown a page confirming your registration:

EUDAMED confirmation message when submitting a certificate registration

From here you can click View the certificate you just created to view the certificate, or you can click the Go to homepage link in order to return to your homepage.