Legislation

REGULATIONS

Regulation (EU) 2017/745 on medical devices (MDR)

• 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

• Corrigenda and an amendment of the regulation were adopted and published that pushed back the regulation’s application to 2021:
  • the first corrigendum was adopted on 13 March 2019 and published on 3 May 2019: link to the first corrigendum [ENG]
  • the second corrigendum was adopted on 3 December 2019 and published on 27 December 2019: link to the second corrigendum [ENG]

  • the regulation amending the dates of application of the MDR was adopted on 23 April 2020 and published on 24 April 2020 – Regulation (EU) 2020/561: link to the regulation amending the MDR [ENG]

• Unofficial consolidated text of the Regulation (EU) No. 2017/745 with amendments. 

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

• 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

• Corrigenda and an amendment of the regulation were adopted and published:
  • the first corrigendum was adopted on 13 March 2019 and published on 3 May 2019: link to the first corrigendum [ENG]
  • the second corrigendum was adopted on 3 December 2019 and published on 27 December 2019: link to the second corrigendum [ENG]

  • Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

• Unofficial consolidated text of Regulation (EU) 2017/746 with amendments. 

ACTS AND RULES

• 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 the manufacture of and trade with medical devices (Official Gazette of the Republic of Slovenia, No. 37/10 )
• Rules on vigilance of medical devices (Official Gazette of the Republic of Slovenia, No. 61/10)
• Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19)

DIRECTIVES

• • Directive 90/385/EC on active implantable medical devices 
  • Directive 93/42/EEC on medical devices 
  • Directive 98/79/EC on in vitro diagnostic medical devices