Safety reporting – according to IVDR

The following shall be fully recorded:

• Any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study.
• Any serious adverse event (SAE).
• 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.

The investigator is responsible for documenting and reporting all serious adverse events and all device deficiencies to the sponsor. The sponsor is then responsible for reporting to the relevant authorities.

Sponsor’s reporting obligations

The sponsor shall report, without delay to the Swedish MPA all of the following:

• Any serious adverse event that has a causal relationship with the device, the comparator or the study 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.

The sponsor shall have an agreement in place to ensure that all these events are reported by the investigators to the sponsor in a timely manner.

All reportable serious adverse events and device deficiencies occurring during the performance study shall be submitted to the MPA in electronic format by using the online e-service.

The reporting shall be made to all relevant authorities in all countries where the performance study is being conducted, not only to the authority in the country where the event has occurred.

Guidance on reporting requirements and timelines

Guidance and timelines for reporting are available in the commission’s guidance document.

Reporting form

The completed form should be submitted to the Swedish MPA through the online E-service.

E-service for SAE reporting

Do like this:

• Please choose the “SAE report Clinical Investigation/Performance study of Medical Device” option as ‘Recipient’ in the e-service drop down menu.
• Add your name and email address in the mandatory fields.
• Attach the file with the report.
• Indicate both the Swedish MPA reference number and CIV-ID of the performance study in the message field.

Safety reporting in performance studies with CE marked products

For performance studies referred to in Article 70.1 of the IVDR, i.e. device which already bears the CE marking and only are used within the scope of its intended purpose, specific safety reporting rules apply as set out in as set out in paragraphs 5 and 6 of Article 76 of the IVDR.

These mean that study-specific reporting via the e-service for SAE reporting is only required for those serious adverse events that have a causal relationship with the preceding performance study. In other respects, incidents are reported by the manufacturer in accordance with the regulations that apply to products that are placed on the market (post-market performance follow-up, PMPF).

For more information, see the web page “Reporting serious incidents page”.