In accordance with Article 110(3) of the IVDR (transitional provisions) and Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices, devices that comply with Directive 98/79/EC may be placed on the market, subject to the pre-fulfilment of the conditions laid down in Regulation 2024/1860/EU and until the dates set out in this Regulation, and provided that they continue to comply with Directive 98/79/EC, that there are no significant changes in the design and intended purpose and that the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, that the manufacturer put in place a quality management system by 26 May 2025 at the latest, that the manufacturer or the manufacturer’s authorised representative has, at the latest by the date specified in Regulation (EU) 2024/1860, related to the risk class of the device, lodged an application for assessment of the conformity of the device with a notified body and signed a written agreement with the notified body to initiate the conformity assessment procedure no later than the dates set out in Regulation 2024/1860/EU. The requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, and of registration of economic operators apply in place of Directive 98/79/EC.
The Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25, ZMedPri-1), applicable as of 19 June 2025, defines device registration and the reporting of changes in Article 45.
Form
In order to comply with the obligations set out in the Medical Devices Act (ZMedPri-1) all changes to the data on a medical device that complies with Directive 98/79/EC must be registered with the competent authority for medical devices, the JAZMP, using Form 876-02.
