Long-awaited new legislation on medical devices comes into effect in the Czech Republic on 1 April 2015. In many respects, the new law brings fundamental changes throughout the industry. In particular, manufacturers, importers and distributors of medical devices now face much more extensive regulatory duties. Paperwork will increase accordingly, and administrative liabilities for any breach of the rules will also be much stricter.
The law seeks to introduce comprehensive regulation of the entire life cycle of medical devices—from the moment of production to the end of usage. Compared with the previous situation, medical devices are now subject to comprehensive legislation, much like medicinal products.
However, unlike medicinal products, medical devices are a much less homogeneous group. Products as diverse as the materials used for medical interventions (dressing material, syringes, needles); medical devices available upon prescription (glucometers, wheelchairs, contact lenses, hearing aids); active implantable medical devices (pacemakers); in vitro diagnostic medical devices (devices for examining blood, urine, etc.); and large medical instruments (X-ray, CT) can all be included in this group. Thus, a single law for such a heterogeneous group of products is a great challenge for the legislature and can cause a number of problems in practice.
The new law brings important changes to several areas:
Clinical trials and performance evaluations
The new law covers areas that so far have only been covered by delegated legislation and/or by guiding EU documents that are not legally binding. This situation has been most apparent in the case of regulations concerning clinical trials and performance evaluations of medical devices, compliance with which has not been frequently legally enforceable under the previous law. The new law contains comprehensive provisions on performance evaluations and strict requirements for the process of the evaluation, including the preparation of final reports.
Registration and notification
The law introduces a new Register of Medical Devices. Primarily manufacturers, importers, distributors and persons providing medical device servicing are to be registered in the Register. The Register will also gather details about the actual medical devices placed on the Czech market. The current obligation to notify the Ministry of Health will be replaced with an obligation to notify the State Institute for Drug Control (SÚKL). Under the new law, not only manufacturers but also distributors and importers will have this notification obligation.
Import and distribution of goods
The law contains new general rules for the import and distribution of goods, which have been designed to preserve the safety and performance of medical devices. Related to this is also, inter alia, the obligation to provide the required information about the product, the obligation to archive documentation for five years, and the obligation to subject medical devices to regular checks.
One of the most serious shortcomings of the outgoing legislation is the fact that surveillance competences were fragmented across seven different authorities, and the performance of these competences was frequently fragmented (the Czech Trade Inspection Authority and trade licensing authorities being the most visible examples). This situation will be eliminated to a large extent, as under the new law the execution of the everyday agenda will be vested in SÚKL, which will primarily be responsible for the registration of persons, notification of medical devices, and checks of persons handling medical devices, as well as for general surveillance over the market. The Ministry of Health has competence over the appeals process and will also exercise certain powers of a more general nature.
Penalties and inspections
The new law introduces a more stringent regime of sanctions. It is now possible to be penalised for a broad range of unlawful practices, including those that were not previously penalised, or for which only a minimal penalty could be imposed (this mainly concerns areas related to the safety and clinical performance of medical devices). The maximum fine for an administrative offence committed by a breach of the law has been increased from CZK 1 million to CZK 2 million. SÚKL will conduct the penalisation procedure and is also in charge of supervising compliance with the law, in particular supervision over the market, inspections of medical devices at healthcare providers, and checks of prices.
In many respects, the new law fundamentally changes the regulation of the medical device industry. There is no question that it will take all concerned stakeholders some time before they become comfortable with the challenges of the new legislation. What can be expected is a quite considerable increase in the regulatory duties for all stakeholders, and that related paperwork will increase accordingly. The concentration of most of the powers with SÚKL also places heavy demands on this authority, and expert circles will watch, expectantly, how this authority copes with this difficult task.
The new law also provides for a National Information System for Medical Devices, which is primarily intended to provide comprehensive information about medical devices to users, patients, and healthcare providers. The system will not be launched until 1 April 2018.
Contrary to original intentions, the new law does not govern advertising for medical devices. In this respect, a certain disharmony will continue to exist in comparison with medicinal products. These are subject to very tight and detailed regulation, whereas medical devices will continue to be governed only by the general provisions of the law on advertising.
In addition, the original proposal on the new regulation of prices and reimbursements has been left unchanged by the final, adopted version of the law. Therefore, efforts to reopen discussion over these issues can be expected in the future. Additional changes will also likely need to be made relating to new EU legislation on medical devices, which is currently being intensively discussed in EU institutions.