The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) also conduct the following procedures in accordance with the applicable legislation:
- Processing of applications pursuant to Article 59 of Regulation 2017/745/EU and Article 54 of Regulation 2017/746/EU
By way of derogation from Article 52 of Regulation 2017/745/EU or Article 48 of Regulation 2017/746/EU, any competent authority may, on the basis of a duly justified request, authorise the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in the aforementioned Articles have not been carried out, where the use of the device is in the interest of public health or patient safety or health.
The instructions and required documentation for submitting an application can be found in the “Exceptional Authorisations” tab.
- Processing of applications for authorisation of reprocessing single-use devices pursuant to Article 14 of the Medical Devices Act
Pursuant to Article 14 of the Medical Devices Act (ZMedPri-1), the JAZMP may, upon the proposal of a healthcare provider and subject to the conditions set out in Article 17 of Regulation 2017/745/EU, decide to include a single-use medical device on the list of devices authorised for reprocessing and further use in Slovenia.
The instructions and documentation required for submitting the proposal can be found in the “Reprocessing” tab.
