JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2025, 74(2):114-116 | DOI: 10.36290/csf.2025.016

Good storage practices for medical devices and in vitro diagnostic medical devices by healthcare providers

Pavla Justová
Státní ústav pro kontrolu léčiv, Praha

To maintain the quality of medical devices and in vitro diagnostic medical devices used in the provision of healthcare, one of the important factors is also the fulfillment of the conditions for their storage set by the manufacturer. Healthcare providers are required to adhere to good storage practices, which are controlled by the State Institute for Drug Control. The aim of this article is to familiarize themselves with the requirements of good storage practices, which are required and controlled by the regulatory authority.

Keywords: medical device, in vitro diagnostic medical devices, healthcare provider, good storage practice, temperature monitoring.

Accepted: May 28, 2025; Published: June 18, 2025  Show citation

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Justová P. Good storage practices for medical devices and in vitro diagnostic medical devices by healthcare providers. Čes. slov. farm. 2025;74(2):114-116. doi: 10.36290/csf.2025.016.
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    References

    1. Nařízení evropského parlamentu a rady (EU) 2017/745 ze dne 5. dubna 2017 o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS (Text s významem pro EHP), Úřední věstník Evropské unie L 117, 5. 5. 2017. http://data.europa.eu/eli/reg/2017/745/2025-01-10.
    2. Nařízení evropského parlamentu a rady (EU) 2017/746 ze dne 5. dubna 2017 o diagnostických zdravotnických prostředcích in vitro a o zrušení směrnice 98/79/ES a rozhodnutí Komise 2010/227/EU, EHS (Text s významem pro EHP), Úřední věstník Evropské unie L 117, 5. 5. 2017. http://data.europa.eu/eli/reg/2017/746/2025-01-10.
    3. Zákon č. 375/2022 Sb., o zdravotnických prostředcích a diagnostických zdravotnických prostředcích in vitro, ve znění pozdějších předpisů. Available from:: https://www.e-sbirka.cz/sb/2022/375?zalozka=text.
    4. Vyhláška č. 377/2022 Sb. o provedení některých ustanovení zákona o zdravotnických prostředcích a diagnostických zdravotnických prostředcích in vitro. Available from: https://www.e-sbirka.cz/sb/2022/377?zalozka=text.

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