Substantial modification – according to IVDR

The sponsor shall notify the Swedish Medical Products Agency (MPA) of planned substantial modifications, which than coordinates the processing with the Swedish Ethical Review Authority if necessary. The sponsor must await the MPA approval before the modifications can be implemented.

Submit the notification

Use the e-service for notification of substantial modifications.

It is also possible to send in notifications of substantial modifications via email, on DVD/CD or USB by post.

Email: registrator@lakemedelsverket.se

Post:
Läkemedelsverket
Box 26
751 03 Uppsala, Sweden

Documentation

The reasons for the proposed substantial modifications shall be clearly indicated in the notification.

Fill in the form for a substantial modification made in accordance with IVDR.

To facilitate the assessment of the modifications, a clean version (without tracked changes) and a version with tracked changes should be submitted for all updated documents.

If new sites are added must evidence showing that the investigators and investigational sites are capable of conducting the performance study according to the clinical performance study plan be provided by the sponsor:

• The qualifications of the investigator shall be demonstrated by a CV, this is applicable for the principal investigator at each investigational site.
• It should be confirmed by a certificate from the responsible person at each investigational site, that the site is capable of conducting the clinical investigation.

When changing the principal investigator at an already approved investigational site, a CV shall be attached for the new principal investigator.

Processing

When a notification of a substantial modification has been received by the Swedish MPA, a confirmation of receipt will be sent to the sponsor.

The Swedish MPA may contact the sponsor during the processing of the notification if it needs to be amended in any aspect. The Swedish MPA may also extend the processing time of 38 calendar days with additional seven calendar days. The sponsor will be notified if such an extension is applicable.

The sponsor needs to wait 38 calendar days after submitting the notification of substantial modification to the Swedish MPA or until the Swedish MPA has issued an approval letter (which may be communicated sooner) before the modification can be implemented.

Ethical review of substantial modification

The Swedish MPA coordinates the processing of substantial modifications with the Swedish Ethical Review Authority if there is a significant modification that is to be assessed by the Ethical Review Authority.

Sponsor fills in the Swedish Ethical Review Authority's form "Notification of change - medical devices" (only in Swedish) that is available at the authority’s website. Sponsor attaches the form together with the notification of substantial modification when submitted to the Swedish MPA.

Relevant documents regarding the substantial modification are forwarded by the Swedish MPA to the Swedish Ethical Review Authority (SERA) for review. The SERA’s opinion is provided to the Swedish MPA. If the performance study includes the use of human biological samples that are regulated in the Biobanks Act (2002: 297), the relevant biobanks/Regional Biobanking Center are also involved.

The Swedish MPA takes into account the SERA's opinion before a decision is made. The decision covers both the review made by the Swedish MPA and the SERA.

If no decision has been issued within 38 days after the notification of a substantial modification has been submitted to the Swedish MPA, including the attached completed application form from the SERA’s website, this means a tacit approval.

Changes in performance studies started before 26 May 2022

Performance studies started before 26 May 2022 may continue to be conducted in accordance with older legislation and substantial modifications to these performance studies do not need to be reported to the Swedish MPA. The sponsor and research principal need to assess for themselves whether a notification of substantial modification to the Ethical Review Authority should be made in the event of modifications to these performance studies.

It may also be necessary to consider whether the modifications are so extensive that it is in fact a new performance study, for which the provisions of IVDR will then be applied.