In accordance with Article 71(1) of Regulation (EU) 2017/746 (IVDR)

If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable.

According to Article 71(3) IVDR, the sponsor may implement the modification at the earliest 38 days after the notification, unless:

(a) the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or

(b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State.

The federal higher authority must therefore inform the sponsor within 37 days of receipt of the notification if it rejects the substantial modification for one of the reasons referred to in Article 71(3) point a of Regulation (EU) 2017/746.

The time limit may be extended by a further seven days if the competent federal higher authority takes expert advice. In this case, it shall inform the sponsor no later than 20 days after receipt of the notification of the substantial modification that the time limit is extended for the purpose of consulting with experts, and at the same time point out that this also extends the time limit under Article 71(3) of Regulation (EU) 2017/746 accordingly (Section 42 of the Medical Devices Law Implementation Act, MPDG).

Procedure

As long as the electronic system referred to in Article 69 (EUDAMED) is not available with a corresponding function, the German Medical Devices Information and Database System (DMIDS, formerly DIMDI) shall be used. The notification of the modification is forwarded in parallel to the competent Ethics Committee and the competent federal higher authority via the system. It must contain an updated version of the relevant documentation in accordance with Annex XIV, Chapter I IVDR. The modifications to the relevant documents must be clearly identified. In addition, the cover letter should address the modifications and their justification.