March 2021 – The Czech parliament has adopted local rules to implement the anticipated entry into force of a new EU Regulation on Medical Devices. The main purpose of the new rules is to increase the safety of medical devices. Additional legislation will also address the advertising of medical devices.
1. New Act on Medical Devices
Regulations concerning medical devices will undergo a significant overhaul in the months ahead. At the EU level, on 26 May 2021, Regulation No. 2017/745 on Medical Devices (“MDR”) will enter into force. The MDR was adopted to increase both the safety of medical devices and the confidence of healthcare providers and patients in the effectiveness, functionality and safety of medical devices. The rules will be uniform across the entire EU market.
Individual EU Member States must adopt local legislation in order to fully incorporate the MDR. To this end, the Czech parliament recently adopted a new Act on Medical Devices (Act No. 89/2021 Coll., the “Act on Medical Devices”). The most relevant provisions include:
- additional regulations for medical device clinical trials, manufacturer and distributor obligations, and for the usage and servicing of medical devices;
- detailed regulations on the prescribing and dispensing of medical devices;
- a definition of the powers of the competent public authorities (the main administrative body in the area of medical devices will continue to be the State Institute for Drug Control);
- the establishment of a Medical Devices Information System (the main purpose is to collect and manage data and to submit notifications and applications to the State Institute for Drug Control);
- the creation of a system of sanctions for violations of the MDR and the Act on Medical Devices (the maximum penalty is CZK 30 million (approximately EUR 1.1 million) for the most severe violations).
2. In vitro diagnostic medical devices
The Czech parliament has also amended the existing Act on Medical Devices (Act No. 268/2014 Coll.), which will be partially repealed; the remaining provisions will continue to regulate only in vitro diagnostic medical devices. However, this is only considered to be an interim solution, as a new EU Regulation on In Vitro Diagnostic Medical Devices (Regulation 2017/746, “IVDR”) is scheduled to enter into force on 26 May 2022. The Czech parliament will need to adopt additional amendments to national legislation in order to harmonise it with the IVDR.
3. Advertising of medical devices
The Czech parliament has also adopted an amendment to Act No. 40/1995 Coll., on the regulation of advertising (the “Advertising Act”), which introduces new, previously absent regulations for medical device advertising, closing what was seen as a loophole in an otherwise heavily-regulated sector.
The new regulations for the advertising of medical devices largely mirror current regulations concerning the advertising of medicinal products. The purpose of the new rules includes addressing the often-misleading claims made by medical device manufacturers concerning the effects of medical devices, thereby better ensuring that patients have more accurate product information.
Pursuant to the new provisions, “advertising” means the promotion of medical devices. In addition, it also means all forms of information, research and incentives carried out to support the prescription, supply, sale or use of medical devices and in vitro diagnostic medical devices.
The regulation of advertising in the amendment to the Advertising Act is designed to ensure that healthcare professionals (“HCPs”) as well as the general public are properly informed. It defines how advertising should be formulated and its respective forms.
Rules for advertising targeting HCPs include:
(i) a ban on providing HCPs with gifts or other compensation for the promotion of medical devices;
(ii) a ban on the provision of disproportionate hospitality and accommodation services provided to HCPs during medical congresses;
(iii) advertising is permitted only through communications channels intended chiefly for HCPs (in particular: professional publications, industry publications, professional audio-visual programming).
Rules for advertising to the general public include the following:
(i) an advertisement must clearly identify the purpose of the medical device, determining whether it is a medical device or an in vitro diagnostic medical device; it must clearly invite a careful reading of user instructions;
(ii) a ban on recommending medical devices with references to recommendations by scientists, HCPs or celebrities;
(iii) a ban on advertising indicating the guaranteed clinical efficacy of a medical device, including exaggerated or misleading advertising concerning cures or the possibility of recovery;
(iv) a ban on the promotion and provision of sample medical devices intended for use by HCPs and on medical devices issued exclusively via a voucher or request form issued by a physician.
The amendments to the Advertising Act also introduce certain restrictions on the use of comparative advertising for medical devices. Such advertising may now only target those persons authorised to prescribe or issue medical devices. Advertising of reimbursed medical devices via competitions, lotteries or other similar games that induce their prescription, supply or usage is also prohibited.
The State Institute for Drug Control will serve as the regulator of advertising for medical devices.
The new rules will enter into force on 26 May 2021.