Legislation

  • Medical Devices Act (Official Gazette of the Republic of Slovenia), No. 98/09
  • Rules on medical devices (Official Gazette of the Republic of Slovenia), No. 37/10, 66/12
  • Rules on manufacturing and marketing medical devices (Official Gazette of the Republic of Slovenia), No. 37/10
  • Rules on vigilance regarding medical devices (Official Gazette of the Republic of Slovenia), No. 61/10
  • Rules relating to fees in the field of medical devices - Initiates file downloadunofficial translation (Official Gazette of the Republic of Slovenia), No. Opens external link in new window24/19

 

On 5 April 2017, new Regulations on medical devices were adopted by European Comission, and they entered into force on 25 May 2017. These replace the existing Directives.

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

     

    On 3 May 2019, corrections were made to both Regulations:  

  • Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. No 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC;

 

  • Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79 / EC and Commission Decision 2010/227 / EU.

     

The new rules will enter into force after the expiration of the transitional period, which means Regulation (EU) 2017/745 (MDR) 3 years from the entry into force, ie from 26 May 2020 and to Regulation (EU) 2017/746 (IVDR) 5 years from the date of entry into force, that is, from 26 May 2022, in addition to complying with the transitional provisions.