On Monday 6 January 2020, the government approved a bill reflecting the European Medical Devices Regulation (“MDR”), effective from 26 May 2020, and partly also the European Regulation on In Vitro Diagnostic Medical Devices, effective from 26 May 2022, in the national legislation. The legislative package also includes fundamental changes in the area of regulation of medical device advertising.
Specifically, the government bill is based on the following European regulations: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices.
New Act on Medical Devices Reflecting the MDR
The adoption of the MDR was intended to harmonise the regulation of medical devices at the European level, as it is in the case of medicines, in order to ensure safety and increase transparency and traceability of medical devices within their distribution.
The MDR reacts primarily to serious cases of quality defects of medical devices that resulted in jeopardising the safety and health of patients (e.g. the well-known cases of defective breast implants covered in the media). Harmonising the regulation of medical devices, their classification, clinical evaluation and vigilance should lead to a consistent application of common European standards on the quality and safety of medical devices across the EU.
The MDR is a regulation, which means it has a direct effect and as such it does not need to be transposed into national laws of the member states, as is the case with directives. Nevertheless, it is still necessary to amend the national legislation so that it complies with the MDR and provides for aspects that the MDR has left in the competence of the member states (e.g. certain rules for prescription, dispensing and use of medical devices and their service, the competence of state administration in the area of medical devices, elements of delicts and relevant sanctions).
Fundamental changes introduced by the MDR:
Definition of a medical device includes e.g. software, nanomaterials, other medical devices and active implantable medical devices or specific cleaning products, and harmonises the definition of medical devices across the EU. The MDR may result in a reclassification of specific medical devices and has a wider scope than the previous European legal regulations. The MDR also introduces a pre-market consultation process for certain high-risk medical devices.
The MDR defines higher standards for clinical examinations of medical devices, introduces a database of clinical evaluation of medical devices, and emphasises the significance of evidence of post-market safety and surveillance of medical devices for the purpose of ensuring the safety of patients.
- Information system of medical devices
The MDR will improve the traceability of medical devices and the transparency of medical devices distribution chain by requiring the disclosure of information on the devices and clinical and functional studies regarding their compliance. The data will be gathered in the new European database of medical devices and in vitro diagnostic medical devices – EUDAMED (European Database on Medical Devices), through which the general public will be informed about new devices introduced to the market. The UDI – a unique identification of a device, a single registration number for the EU market, will enable the identification of each specific device on the market and will significantly strengthen the traceability and efficiency of activities related to the post market supervision of a medical device.
- Vigilance and market supervision
The MDR focuses on supervision over the manufacturing of medical devices and requires that manufacturers introduce a comprehensive post-market surveillance system established as part of their quality management system and based on a post-market surveillance plan. The new national draft act on medical devices focuses primarily on the records of serious adverse events or the implementation of safety remedial measures in the territory of the Czech Republic.
Regulation of Advertising of Medical Devices
Advertising of medical devices has not been subject to specific regulation exceeding the scope of general requirements on advertising (e.g. compliance with accepted principles of good morals, limitation of advertising representing an unfair business practice, etc.).
Newly, it will be regulated similarly to medicines. The Act on Regulation of Advertising includes new specific rules for medical devices and in vitro diagnostic medical devices. Advertising of medical devices will include “also all forms of informing, survey or incentives performed with the purpose of supporting prescription, dispensation, sale, or use of medical devices or in vitro diagnostic medical devices”, primarily e.g. sales representatives visiting persons authorised to prescribe medical devices, supply their samples or sponsor scientific meetings, or meetings held for the purpose of promoting such devices.
The amendment divides the advertising of medical devices into activities aimed at the general public, and professionals, and it states specific rules for each type. The act newly bans certain types of advertising, e.g. advertising of medical devices covered partly or fully by the health insurance system. It must be added that the regulation of advertising of medical devices does not originate in the European legislation.
Amendment to the Existing Act on Medical Devices
The current legislation, represented by Act No. 268/2014 Coll., on Medical Devices, and the amendment to Act No. 634/2004 Coll., on Administrative Fees, as amended, is modified so that it will only regulate in vitro diagnostic medical devices. It is a provisional solution applicable until the regulation of in vitro diagnostic medical devices becomes effective, i.e. 26 May 2022.