New SÚKL guidelines for medical devices and in vitro medical devices
We would like to inform you that SÚKL has issued new guidelines UST-39, UST-41, UST-42 with effect from 31 October 2023 and UST-40 with effect from 1 November 2023.
The full text can be found here:
The new versions of the guidelines only expand the existing wording, while SÚKL reflects the new legislation and an amendment to the Act on Advertising, which, among other things, allows targeting advertising (except for comparative advertising) for medical devices that are dispensed based on a prescribed or intended for use by a medical professional also to employees of health care providers.
In addition to changes of a rather formal nature, the guidelines specify in particular the following:
- Definition of an employee of a health service provider
This refers to a person who uses the MD and MD IVD in a direct context in the provision of health care according to the professional competences set out by the legislation.
The definition also covers a person who makes selections, orders, purchases of MD and MD IVD for the health service provider.
- Requirements for advertising to the general public
In advertising to the general public, the best practice is to use the words ‘medical device’ or ‘in vitro diagnostic medical device’ to formulate the requirement that the device is a MD or MD IVD.
The formulation of the nature of the intended use should be based on the information provided by the manufacturer as part of the conformity assessment process for the MD or MD IVD being advertised. The period of issue of the declaration of conformity for the MD or MD IVD subject to the advertisement shall be consistent with the period of the assignment, the processing of the advertisement. In the case of an extensive intended use, a notice may be included in addition to the substance of the intended use that the MD or MD IVD has a more extensive intended use, which will be available on request, in a reference, etc. Both aforementioned requirements need to be met when formulating the invitation to read carefully the instructions for use of the MD or MD IVD and the information relating to its safe use. Replacing this invitation and information with a reference to the answers to questions (FAQs), even if included in the advertisement, will be considered insufficient.
- Requirements for advertising aimed at professionals
The formulation of the requirement to provide sufficient, verifiable and objective data should be based on the data provided by the manufacturer as part of the conformity assessment process for the MD or MD IVD that is the subject of the advertisement. The period of issue of the declaration of conformity for the MD or MD IVD subject to the advertisement must be consistent with the period corresponding to the assignment, the processing of the advertisement. According to Article 2, point 53 of the EU Regulation 2017/745 on MD “For the purposes of this Regulation, ‘clinical benefit’ means: a positive impact of a device on the health of an individual expressed as meaningful, measurable, with a clinical outcome or outcomes relevant to patients, including an outcome or outcomes relating to diagnosis, or a positive impact on the treatment of patients or on public health”. According to Article 2, point 22 of the EU Regulation 2017/745 on MD “For the purposes of this Regulation: ‘efficacy’ means the ability of a device to fulfil its intended purpose as specified by the manufacturer”. Thus, in the context of advertising, the safety requirement will be met by the CE marking as issued by the manufacturer or the declaration of conformity for the MD or MD IVD that is the subject of the advertisement.
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