In accordance with Article 120(3) of the MDR and Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, devices that comply with one of the aforementioned Directives may be placed on the market until the specified dates in Regulation 2023/607/EU, subject to the pre-fulfilment of the conditions laid down in the aforementioned Regulations and provided that they continue to comply with any of those Directives, that there are no significant changes in the design and intended purpose and 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 2024 at the latest, that the manufacturer lodged a formal application with a notified body by the same date, and, that the notified body and the manufacturer signed a written agreement to initiate the conformity assessment procedure of the device by 26 September 2024 at the latest. The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, and of registration of economic operators apply in place of the corresponding requirements in these Directives.
Exception: As of 26 May 2021, risk class I devices can only be placed on the market if they comply with the MDR.
The Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25; hereinafter ZMedPri-1), applicable as of 19 June 2025, addresses 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 93/42/EEC or Directive 90/385/EEC must be registered with the competent authority for medical devices, the JAZMP, using Form 875-02.
