Document 57 - Amendment to the Act on Medical Devices and In Vitro Diagnostic Medical Devices - EU - RJ

Processed date: 09.12.2025 |Session 10

Submitters: Vláda

Summary

The amendment introduces a new system for mandatory reporting of interruptions or discontinuations in the supply of medical devices by manufacturers, distributors, and healthcare providers, to be done electronically via the Medical Devices Information System. The Institute gains significantly broader powers to investigate the unavailability of devices and can request data from all parts of the supply chain. The Ministry of Health is newly granted the authority to issue rapid general measures, allowing it to temporarily regulate the introduction, distribution, prescription, or use of devices in the event of an impending or actual shortage. Penalties for failing to meet these reporting obligations or violating the conditions set by the measures are significantly tightened, with fines reaching up to CZK 15 million.

The aim of these changes is to enable timely responses to potential shortages of devices and to ensure the availability of healthcare in accordance with new European regulations.

Topics

Additional documents

Additional document 1

Act from the Senate – Print 57/0

Processed date: 07.05.2026

The proposal modifies the amendment returned by the Senate to introduce mandatory reporting of imminent interruption or termination of the supply of medical devices and to expand the powers of the Institute and the Ministry of Health to deal with their unavailability. Manufacturers, distributors, importers and health service providers will be required to provide data on request, and the Ministry will be able to temporarily regulate the marketing, distribution, prescription, dispensing and use of devices by means of a measure of a general nature. The proposal also adds new offences and penalties for failure to comply with information obligations or breach of these measures. Electronic reporting is to be made temporarily via a form on the Institute’s website, and later via the medical device information system.

Additional document 2

Senate Resolution on Print No. 57/0

Processed date: 07.05.2026

The Senate returns the amendment on medical devices to the Chamber of Deputies with amendments. The amendments mainly specify that a manufacturer established in the Czech Republic or its authorised representative should report interruptions or termination of supply to the Institute electronically via a form on its website, delete one original point of the proposal and modify related references in the sanction and procedural provisions. The Senate also adds a rule for the issuance and revocation of a general measure and proposes that the law take effect the day after its promulgation.

Laws affected by this document

375/2022

Zákon o zdravotnických prostředcích a diagnostických zdravotnických prostředcích in vitro