Safety reporting

For this type of investigations, sponsors are responsible for reporting to the relevant authorities in accordance with the requirements of Article 80(1) to (4) of the MDR, the guidance document MDCG 2020-10/1 rev 1 and national legislation.

This means that sponsors must report the following reportable cases to the Swedish MPA without delay:

• any serious adverse event (SAE) that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible
• any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate
• any new findings in relation to any of the events above.

Safety reporting is done using the form "Clinical investigation summary safety report form" MDCG 2020-10/2 rev 1 which is sent to the Swedish MPA via the Agency’s e-service for SAE reporting. The form and the e-service are linked further down this page.

Reports shall be submitted to the relevant authorities in all countries where the clinical investigation is conducted, not only to the authority of the country where the event occurred.

For this type of investigations, sponsors are responsible for reporting to the relevant authorities in accordance with the requirements of Article 80(5)-(6) of the MDR, the guidance document MDCG 2020-10/1 rev 1 and national legislation.

This means that sponsors must report the following reportable cases to the Swedish MPA without delay:

• any serious adverse event (SAE) for which a causal relationship to the preceding investigational procedure has been established.

Safety reporting is done using the form ‘Clinical investigation summary safety report form’ MDCG 2020-10/2 rev 1 which is sent to the Swedish MPA via the Agency’s e-service for SAE reporting.

The form and the e-service are linked further down this page.

Reporting shall take place to the relevant authorities in all countries where the clinical trial is conducted, not only to the authority of the country where the event occurred.

Since the investigational device is CE marked and used within the scope of its intended purpose, serious incidents and adverse events must also be reported in accordance with the requirements applicable to CE marked devices. This means that for serious incidents and adverse events occurring in Sweden:

• the manufacturer reports serious incidents to the Swedish MPA
• healthcare notifies the manufacturer and the Swedish MPA of adverse events and incidents involving medical devices.

For investigations in Sweden with CE-marked investigational devices used within the scope of the intended purpose defined by the manufacturer, where subjects are not exposed to any additional invasive or burdensome procedures due to the investigation, no investigation-specific safety reporting shall be made to the authority within the framework of the investigation.

However, since the investigational device is CE marked and used in line with its intended purpose, serious incidents and adverse events must be reported in accordance with the requirements applicable to all CE marked devices.

This means that for serious incidents and adverse events occurring in Sweden:

• the manufacturer reports serious incidents to the Swedish MPA
• healthcare notifies the manufacturer and the Swedish MPA of adverse events and incidents involving medical devices.