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Territory – Czech Republic
Ministry of Health CZ NOH
Language – Czech
Territory – Czech Republic
Statni ustav pro kontrolu leciv (SUKL) State Institute for Drug Control
Language – Czech
Medical Devices Branch
- Clinical evaluation of Medical Devices
- Registration and Notification
- Performance studies
- Vigilance system
Subscribe to Medical Devices Branch
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 “MDR”) establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety became applicable.
On 26 May 2021, 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 (hereinafter referred to as the “IVDR”) 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 MDR and IVDR, the Act No. 375/2022 Coll., on medical devices and on in vitro diagnostic medical devices (hereinafter referred to as the “Act on Medical Devices”) became applicable on 22 December, 2022 for the area of medical devices in the Czech Republic.
Previous legislation:
Registry of medical devices
The registry of Medical Devices shall mean pursuant to Act No. 268/2014 Coll. on Medical Devices and on Amendments to Act No. 634/2004 Coll., on Administrative Fees, as amended, a public administration information system intended for the collection of data about
- medical devices placed on the market in the Czech Republic
- persons registered pursuant to Act on Medical Devices
- adverse incidents and field safety corrective actions
- conducted clinical investigations of medical devices
- certificates issued by notified bodies established in the Czech Republic
To enter the registry of Medical Devices click here