Until EUDAMED is fully functional, the sponsor must notify the JAZMP of any modification to the documentation referred to in Chapter I of Annex XIV to the IVDR within one week of the modification occurring, in accordance with Article 66(2) of the IVDR. This notification can be submitted either in person at the JAZMP head office or by post to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, in accordance with paragraph two of Article 63 of the General Administrative Procedure Act (ZUP). The sponsor must attach updated relevant data and ensure that the affected modifications in the documentation are clearly identifiable.
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 the JAZMP of the reasons for these modifications and their nature within one week, in accordance with Article 71 of the IVDR.
The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV to the IVDR in the notification, ensuring that any modifications to the relevant documentation are clearly identifiable.
Any substantial modification of the performance study is to be assessed by the JAZMP in accordance with the procedure laid down in Article 67 of the IVDR.
In accordance with Article 71 of the IVDR, any substantial modification to a performance study must be notified to the JAZMP using the dedicated form: Performance study – Substantial modification of performance study under In Vitro Medical Device Regulation (Notification form Version 1.0), which is available in MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746. The submission method is the same as for an application for authorisation of a performance study. The above applies until the Clinical Investigations and Performance Studies Module is made available in the European Database on Medical Devices (EUDAMED).
Notified modification may be implemented if the JAZMP or the KME RS has not issued a negative opinion within 38 days of notification being notified.
The Member State(s) concerned may extend the period referred to in Article 71(3) of the IVDR by a further seven days for the purpose of consulting with experts.
Article 27 of the Medical Devices Act (ZMedPri-1) applies mutatis mutandis to substantial modifications to the performance study referred to in Article 71 of the MDR, with regard to the validation or assessment of such modifications.
