2020/0006/CZ
EC/EFTA
CZ Tschechische Republik
  • S10S - Medizinprodukte
2020-04-08
2020-01-14

Medical devices as defined by Regulation (EU) 2017/745 of the European Parliament and of the Council 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, and Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices

Draft Act amending Act No 268/2014 on medical devices and on amendments to Act No 634/2004 on administrative fees, as amended, Act No 634/2004 on administrative fees, as amended and Act No 40/1995

on the regulation of advertising and on amendments to Act No 468/1991 on the operation of radio and television broadcasting, as amended, as amended

The draft act responds to the adoption of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (hereinafter the ‘MD Regulation’) and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (hereinafter the ‘IVD Regulation’).

In light of the scope of the changes necessary at the level of national legislation, the MD Regulation will be implemented by creating a new act on medical devices.

The MD Regulation and the new act will hence replace the existing legislation on medical devices.

The proposed amendment to the Act will retain the existing legislation on in vitro diagnostic medical devices even after the MD Regulation and the new act on medical devices have entered into force, until the IVD Regulation enters into force.

In a footnote, the present draft refers to standard ČSN EN 62353, 2nd edition,

catalogue number 97147. This standard was uploaded to the Trisv2 database under ‘Other text’.

keywords: medical devices, in vitro diagnostic medical devices