Processing of applications and notifications – according to IVDR

The sponsor is responsible for submitting a complete application or notification to the Swedish MPA.

Application

Validation – Application in line with Articles 66.7 and 66.7b IVDR

When an application of a performance study is received by the Swedish MPA, a validation of the submitted documents will be performed. This means to verify if the performance study falls within the scope of the regulatory framework IVDR and if the application is complete. If the application is deemed valid, the sponsor will be notified via a validation decision and receive a validation date.

If the application is deemed to be not complete or if the performance study does not fall within the scope of the regulation, the Swedish MPA will notify the sponsor within 15 calendar days. The sponsor will then be given opportunity to comment or to complete the application with additional information. The requested information must be submitted to the Swedish MPA within the given timelines, usually 30 calendar days.

When the requested information has been submitted to the Swedish MPA, a new validation of the application will be performed. If the requested additional information is not received within the given timeline, the application will be considered to have lapsed.

After receiving the requested information, the Swedish MPA shall, within ten calendar days at the latest, notify the sponsor of whether the application is deemed valid or not:

• If the application is not deemed valid, the sponsor will receive a negative decision (rejection letter). The negative decision can be appealed.
• If the application is deemed valid, the sponsor will be notified about the validation date via a validation decision. The notice will also inform the sponsor whether the application is subject to further assessment by the Swedish MPA, depending on the design and conduct of the performance study.

Applications for performance studies where surgically invasive sampling is performed only for purpose the study, but where sampling does not pose a major clinical risk to the subject, are processed in accordance with Article 66.7a of the IVDR. Other applications are processed in accordance with Article 66.7b of the IVDR. Both processes are described in more detail below.

A valid application is forwarded by the Swedish MPA to the Swedish Ethics Review Authority for ethical review. If applicable, will the submitted documents also be forwarded to the relevant biobanks/Regional Biobank Centres. More information about the separate biobank application that sponsor must send directly to the Regional Biobank Centre can be found on the page” Application and notification - according to IVDR.”

Processing – Application in line with Article 66.7b IVDR

The processing time for applications for performance studies in accordance with Article 66.7b of the IVDR is up to 45 calendar days after the validation date. In addition, the time sponsor needs to respond to a possible request for additional information from the Swedish MPA is added to the 45 calendar days.

1. Valid application:

• The Swedish MPA validates the application, sends a validation decision and invoices the application fee.
• The documents are forwarded to the Swedish Ethics Review Authority for assessment.

2. Initial assessment:

• The Swedish MPA and the Swedish Ethical Review Authority make an initial assessment.
• The Ethics Review Authority sends an opinion to the MPA.
• The MPA compiles any questions from both authorities and sends them to the sponsor
• The clock stops/pauses in the up to 45 days long processing time.

3. The sponsor is given the opportunity to complement if necessary:

• The Swedish MPA announces a response deadline, but it can be extended if the sponsor needs more time.
• When the sponsor submits the requested additional information to the Swedish MPA, the clock starts again and the remainder of the total 45-day processing time begins to run.

4. Final assessment:

• The Swedish MPA and the Ethical Review Authority make a final assessment based on the supplemented application.
• The Swedish MPA receives an opinion from the Ethics Review Authority.

5. Decision:

• The Swedish MPA makes a decision, taking the Ethical Review Authority's opinion into account, and notifies the sponsor.

The decision that is announced thus includes both the Swedish MPA and the Swedish Ethics Review Authority's assessment of the application.

Processing – Application in line with Article 66.7a IVDR

For applications for performance studies processed in accordance with Article 66.7a of the IVDR, the processing time is up to 40 calendar days after the validation date.

The Swedish MPA sends a validation decision when the application is deemed valid and then it is the Swedish Ethical Review Authority that decides whether the performance study may be authorised and commenced, authorised subject to conditions, or whether authorisation has been refused. The Swedish Ethics Review Authority sends its decision to the sponsor no later than 40 calendar days after the validation date.

1. Valid application:

• The Swedish MPA validates the application, sends a validation decision and invoices the application fee.
• The documents are forwarded to the Swedish Ethics Review Authority for assessment.
• Ethical review performed at a meeting.

2. The sponsor may be given the opportunity to complement:

• The Swedish Ethics Review Authority sends questions to the sponsor and states a deadline for response.
• The opportunity for the sponsor to complement the application is given only if time permits.

3. Completion is assessed:

• The sponsor sends the requested information to the Swedish Ethical Review Authority, which makes a final assessment based on the supplemented application.

4. Decision:

• The Swedish Ethics Review Authority makes a decision and notifies the sponsor.

Notification

Processing – Notification in line with Article 70.1 IVDR

For performance studies that require a notification in accordance with Article 70.1 of the IVDR, a notification must be submitted to the Swedish MPA at least 30 days before the start of the performance study.

When the Swedish MPA has received a complete notification, an acknowledgment of receipt is sent to the sponsor and the notification is forwarded to the Swedish Ethical Review Authority, which decides whether the performance study may be authorised and commenced, authorised subject to conditions, or whether authorisation has been refused.

The Swedish Ethics Review Authority notifies the sponsor of its decision no later than 30 calendar days after the complete notification has been received by the Swedish MPA. The sponsor may not start the study until at the earliest 30 days after a complete application has been received by the MPA.

If applicable, will the notfication also be forwarded to the relevant biobanks/Regional Biobank Centres.

More information about the separate biobank application that sponsor must send directly to the Regional Biobank Centre can be found on the page” Application and notification - according to IVDR.”

1. Complete notification:

• The Swedish MPA performs a control of the notification, sends an acknowledgment of receipt to the sponsor and invoices the notification fee.
• The documents are forwarded to the Swedish Ethics Review Authority for assessment.
• Ethical review performed at a meeting.

2. The sponsor may be given the opportunity to complement:

• The Swedish Ethics Review Authority sends questions to the sponsor and states a deadline for response.

3. Completion is assessed:

• The sponsor sends the requested information to the Swedish Ethical Review Authority, which makes a final assessment based on the supplemented notification.

4. Decision:

• The Swedish Ethics Review Authority makes a decision and notifies the sponsor.

Notification of substantial modification