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 on medical devices

This 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’).

With a view to 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.

This is comprehensive legislation aiming, in particular, at ensuring the safety of medical devices for patients, including thanks to additional provisions on prescribing, dispensing, using or servicing medical devices.

At the same time, it is proposed to amend the existing Medical Devices Act so that the current provisions on in vitro diagnostic medical devices are retained even after the MD Regulation and the new act on medical devices enter into force, specifically until Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices becomes effective.

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