With regard to the adoption and forthcoming application of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (“MDR”) and Regulation (EU) 2017/746 of the European Parliament and of the Council on diagnostic medical devices in vitro (“IVDR”), the Czech legislation in the field of medical devices is likely to undergo a major transformation. Currently, several proposals of laws have been published by the Government of the Czech Republic with the aim of adapting the Czech laws to MDR and IVDR.
In general
The proposal for a completely new act on medical devices was published to the comment procedure and shall primarily regulate residual questions for general medical devices.
At the same time, an amendment to the existing Act on Medical Devices was proposed, which among other things shall bring changes to the name of the act itself, as well as amendments to its provisions, which will newly focus on diagnostic medical devices in vitro.
Legislative activity in relation to medical devices are also reflected in another acts. Specifically, changes in the regulation of advertising of medical devices are proposed, in particular setting out special requirements for the contents of advertisements, which are inspired by the current regulation of advertising of medicinal products.
New Act on General Medical Devices
With regard to the direct applicability of MDR, the proposal of the new act shall regulate only the areas of regulation of medical devices which MDR allows to modify at the national level or which it does not regulate at all.
The act shall apply only to general medical devices, i.e. not to diagnostic medical devices in vitro, which shall be subject to a separate act on diagnostic medical devices in vitro.
The proposed act regulates, inter alia, the powers of administrative authorities in the exercise of state administration in the field of medical devices, the National Information System of Medical Devices, prescribing and dispensing of medical devices, their use and conditions of their service and the sanctions, offenses and breaches of the obligations laid down by the MDR and the obligations laid down in the new act.
Transformation of the current Act on Medical Devices to the Act on Diagnostic Medical Devices in vitro
As part of the proposal of the latter act, it is proposed that as of 26 May 2022 the Act on Medical Devices shall change its name and modify only diagnostic medical devices in vitro. The mentioned shall happen because the regulation of diagnostic medical devices in vitro based on EU Directive 98/79/EC shall cease to exist with the applicability of MDR.
For clarification, an in vitro diagnostic medical device is a medical device that is the reagent, the result of the reagent reaction, the calibrator, the control material, the kit, the instrument, the device or system, used alone or in combination, which is intended by the manufacturer to examine in vitro samples, including donated blood and tissues obtained from the human body solely or predominantly to obtain information on the health of the patient.
The proposed law also shall regulate partial aspects of the clinical trial, including performance evaluation, reporting obligations for distributors and service personnel, and also prescribing, dispensing (including mail-order dispensing), use or possible confusion and service of medical devices. Also, it shall regulate the training of medical staff who may come into contact with the medical devices in vitro in any form.
Amendment to the Act on Advertising Regulation
Although MDR does not directly provide for the regulation of advertising, the legislator proposes a completely new, specific legislation on the advertising of medical devices, which encompasses both diagnostic medical devices in vitro and general medical devices as part of an amendment to the Advertising Regulation Act. The new legislation is intended to bring special regulation of advertising based on the target thereof.
In the case of targeting the general public, the specific content requirements of the advertisement, such as a clear indication of the medical device and identification of the nature of the medical device must be included.
Furthermore, the proposed law shall forbid referring to a given device with reference to the recommendations of scientists, health professionals or public figures. Advertising shall also prohibit to indicate the guaranteed clinical effectiveness of the device, including advertising that points to the possibility of healing in an exaggerated or misleading manner.
Where advertising is targeted at professionals, the draft shall also introduce specific rules regulating not only the content of advertising. It shall be prohibited to engage professionals for remuneration and to provide them with gifts or other remuneration for the promotion of the medical devices. The rule also applies to inadequate hospitality and accommodation provided to professionals during congresses.
In addition to the specific characteristics which advertising based on its recipients may not have, generally, the restriction on the admissibility of comparative advertising of medical devices should be limited only to persons authorized to prescribe or supply medical devices.
State Institute for Drug Control shall be a supervisory authority in the field of the advertising of medical devices.
Conclusion
All the above-mentioned proposed laws are currently in the comment procedure. According to the proposed wording, the acts in question shall enter into force on 26 May 2020.
The proposed legislation on medical devices will have a significant impact on the current legislation not only in the primary regulation area, but it will also affect other laws, such as those regulating advertising.
We will continue to monitor the legislature process and inform you thereof.
In case of any questions we are at your disposal, please do not hesitate to contact us
Mgr. Jakub Málek, partner – malek@plegal.cz
Eliška Vetýšková, legal assistant – vetyskova@plegal.cz
31. 10. 2019