Legislation

On 26 May 2021, 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 (hereinafter referred to as the "Medical Device Regulation") establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety became applicable.

Following the directly applicable Medical Device Regulation, the Act No. 89/2021 Coll., on Medical Devices and on Amendment to Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as the “Act on Medical Devices”) became applicable for the area of medical devices in the Czech Republic.

Diagnostic medical devices in vitro fall within the scope of Act No. 90/2021 Coll, amending Act No 268/2014 Sb., on Medical Devices and on Amendment to Act No 634/2004 Coll., on Administrative Fees, as amended, Act No 634/2004 Coll., on Administrative Fees, as amended, and Act No 40/1995 Coll., on Advertising Regulation and on Amendment to Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting,  as amended (hereinafter referred to as the “Act on In Vitro Diagnostic Medical Devices”).

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