Persuant to Article 8 of the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25; hereinafter: ZMedPri-1) and based on Article 59 of Regulation 2017/745/EU or Article 54 of Regulation 2017/746/EU, and particularly in emergency situations where the use of a medical device is in the interest of protecting public health, or the health and safety of users, the JAZMP may authorise the placing on the market or putting into service of a specific device within 60 days of receiving a complete application on the territory of the Republic of Slovenia. This applies to devices for which the applicable conformity assessment procedures under Articles 52 of Regulation 2017/745/EU or Article 48 of Regulation 2017/746/EU have not been carried out.
- the manufacturer of the medical device,
- the manufacturer’s authorised representative,with the manufacturer’s consent,
- the importer or distributor, with the manufacturer’s consent.
The JAZMP, in agreement with the minister responsible for health, determines the content of the application for a derogation from the conformity assessment procedures under Articles 52 and 48 of Regulations 2017/745/EU and 2017/746/EU, respectively, by means of a general act that is currently being drafted.
NOTE: Compassionate use of a medical device is not defined in the legislation applicable in the Republic Of SloveniaSlovenia and has no legal basis under Regulation 2017/745/EU or Regulation 2017/746/EU.
