Legislative changes in the field of medical devices

15. 2. 2023

Authors: František Neuwirth, Denisa Fuchsová

In December 2022 and January 2023, new legislation on medical devices and in vitro diagnostic medical devices (jointly “medical devices”) came into force:

• an amendment to the Act on Advertising Regulation, which responds to practical difficulties encountered in the application of the existing regulation of advertising of medical devices;
• a brand new Medical Devices Act that unifies national regulation of medical devices;
• a new price regulation which, among other things, regulates the maximum year-on-year increase in the originator price in 2023.

We provide an overview of the most important changes in this post.

AMENDMENT TO THE Act on Advertising Regulation

Amendment to Act No. 40/1995 Sb. on Advertising Regulation, as amended, relaxes some of the requirements for advertising of medical devices that have proven problematic in practice.

Catalogues and price lists

The amendment provides for an exemption from the application of the Act on Advertising Regulation for sales catalogues and price lists, which have not been previously allowed to contain a description of the characteristics of medical devices. It is now explicitly allowed for catalogues and price lists to contain a basic description of the device necessary for its identification.

If it is just such a basic description, then the catalogue or price list will not be considered as advertisement. Pursuant to the explanatory memorandum [1], this clarification was made in order to allow indicating the basic parameters of the medical device in the aforementioned materials, which are necessary for correct identification and thus the subsequent ordering of the correct medical device. This change therefore responds to practical needs. Indeed, it has become clear that in many cases the mere name of a medical device is not of itself sufficient for its unambiguous identification.

Recipients of advertising of medical devices

The amendment allows advertising of medical devices to target not only “professionals” in the narrow sense of the word (i.e. persons authorised to prescribe or dispense), but also employees of healthcare providers whom the amendment places at an equal level with professionals. This means that medical devices, which until now could only be advertised to professionals, can now also be advertised to employees of healthcare providers who do not fall under the statutory definition of professional, such as laboratory technicians.

The explanatory memorandum specifies that this addition was made “in view of the wide variety of medical devices and the individuals who use them in the provision of health services, where the use itself is not only the responsibility of doctors, who were the only ones falling under the previously stated definition of professional, but also involves other professional staff which includes, for example, nurses, biomedical engineers and purchasing department staff”. At the same time, however, the prohibition on gifts is extended to employees of healthcare providers.

Mandatory information in advertising

The amendment also modifies the scope of mandatory information in advertisements targeted at lay persons, the so-called “legal line”. Instead of stating the “intended purpose” in the advertisement, it will now be sufficient to state the substance of the intended purpose. According to the explanatory memorandum “this clarification was made in view of the fact that the full intended purpose of use stated in the instructions for use may be so extensive that if the interpretation that the full intended purpose must be stated were to continue to apply, it would render the advertisement technically impracticable”.

In relation to mandatory information in advertising targeting professionals, the amendment departs from the obligation to include in the advertisement the basic information contained in the instructions for use, the so-called abridgement.

In practice, this obligation caused significant problems, as there was no precise stipulation anywhere as to what information was considered basic, and the administrative authorities left this assessment to the advertisers. Especially with more complex instruments, where instructions for use often consisted of hundreds of pages, it was not possible to “condense” the instructions into abridged information.

However, an advertisement still must contain sufficient, demonstrable and objective data to enable the professionals to form their own opinion on the clinical benefit of the device in question, and now also on its safety and effectiveness.

NEW ACT ON MEDICAL DEVICES

The new Act No. 375/2022 Sb. on Medical Devices and In Vitro Diagnostic Medical Devices (the “Medical Devices Act”) was adopted in furtherance of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”). This brings about unification of national legislation on medical devices.

Due to the late applicability of the IVDR, national legislation has been split so far – general medical devices were regulated by Act No. 89/2021 Sb. on Medical Devices (“Act 89/2021”), while in vitro diagnostic medical devices were regulated by Act No. 268/2014 Sb. on In Vitro Diagnostic Medical Devices (“Act 268/2014”). Both of these Acts have been repealed and replaced by the new Medical Devices Act.

As stated in the explanatory memorandum [2], the Medical Devices Act largely adopts the existing regulation contained in Act 89/2021, extending it to in vitro diagnostic medical devices. However, upon closer examination of the new Medical Devices Act, it is clear that the legislator has also made several partial substantive changes, which are discussed below.

Borderline products: new ex officio proceedings for annulment of a decision

The Medical Devices Act has taken over from Act 89/2021 the provisions regarding the proceedings for a decision on a so-called borderline product, i.e. the proceedings to determine whether or not a product falls within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (“MDR”), and henceforward also within the scope of the IVDR. However, under the MDR and IVDR, the European Commission too can decide on the nature of a product or group of products by means of implementing acts.

In practice, this could result in the previously issued decision of the State Institute for Drug Control (the “Institute”) coming into conflict with a decision of the European Commission. Previously, this situation had not been explicitly addressed in the legislation. With the adoption of the new legislation, however, the obligation of the Institute to annul the previously issued decision in proceedings initiated ex officio is clearly established. Given that the Medical Devices Act expressly stipulates that proceedings are initiated ex officio, proceedings cannot be initiated at the request of the person concerned. Those persons will thus only be able to submit motions to the Institute to initiate the proceedings.

Registration of medical devices

As regards the registration of medical devices, the MDR or IVDR, respectively, foresees that this will take place exclusively at European level, with medical devices being registered only by manufacturers in the European Database on Medical Devices (EUDAMED).

However, the Medical Devices Act continues to impose a limited reporting duty on distributors in the Czech Republic in relation to medical devices distributed by them – distributors are obliged to report the primary identifier of the device model (Basic UDI-DI) and the intended purpose of the medical device; if these data are not available in EUDAMED, the distributor will report the trade name and the name of the generic device group.

This reporting duty is to be fulfilled by distributors through the Medical Device Information System, which has not been established yet. Until its establishment, medical devices will be reported through the existing Registry of Medical Devices.

Prohibition of supply of a medical device to a lay person

The Medical Devices Act also contains an explicit prohibition of the supply of a medical device whose dispensing is mandatorily linked to the so-called safety pass, and of a diagnostic medical device (with the exception of a diagnostic medical device designated by the manufacturer for self-testing and a diagnostic medical device of risk class A) to a lay person. Pursuant to Article 2(38) of the MDR and Article 2(31) of the IVDR, respectively, a lay person is “an individual who does not have formal education in a relevant field of healthcare or medical discipline”.

Changes to instruction

With regard to the area of instruction, the explanatory memorandum to the Medical Devices Act states that the existing provisions contained in Act 89/2021 are merely taken over and modified so as to also cover in vitro diagnostic medical devices. However, compared to the wording of Act 89/2021, there is at least one change that may have an impact on practice, namely omitting the authorised representative from the list of persons who can perform instruction or authorise training centres to train instructors.

Therefore, it is now the case that if an authorised representative were to perform instruction, he or she will need to have the manufacturer’s authorisation. Similarly, the training centre must now be authorised directly by the manufacturer to train instructors – authorisation by an authorised representative will no longer be sufficient.

This may have practical implications, especially in view of the fact that manufacturers are often foreign entities which are not familiar with the specifics of the Czech law and automatically consider the authorised representative to be a person who is entitled to fulfil the manufacturer’s statutory obligations in the full scope.

Retention obligation for spare part distributors

The Medical Devices Act contains a new retention obligation for persons who make available spare parts of medical devices, for a period of 10 years from the date on which they supplied the spare part. The law somewhat inaccurately states that the retention obligation applies to “supporting evidence”, while it is not clear from the wording of the Medical Devices Act itself what is meant by supporting evidence. However, in conjunction with the MDR and IVDR, respectively, it is obvious that the reference is meant to be to supporting evidence demonstrating that it was ensured that the component in question did not adversely affect the safety and performance of the medical device.

NEW PRICE REGULATION

The Ministry of Health has issued a new price regulation No. 1/2023/OLZP on the regulation of prices of medical devices and diagnostic medical devices, effective from 1 January 2023. Below is a list of the main changes compared to the previous price regulation (No. 1/2019/CAU of 2019):

Maximum year-on-year increase in the price of the originator: In 2023, the originator’s price can be increased by a maximum of 8% compared to the highest price applied by the originator in 2022. In 2022, it was only 3%.

Narrowing down the groups of medical devices for which the market is not expected to be threatened in terms of competition: The previous price regulation established a presumption that for the listed groups of medical devices there would, “as a rule”, be no threat to the market in terms of competition.

The new price regulation has removed the following from the applicability of that presumption:

(i) reimbursement groups listed in Annex 3 to the Public Health Insurance Act, which include at least 4 substitutable medical devices from 4 different notifiers; and

(ii) groups of separately billed medical material or directly consumed medical material that include at least 4 substitutable separately billed medical materials or directly consumed medical materials from 4 different originators.

This has left only one group of medical devices within the presumption, namely the group of substitutable devices created under Section 39u of the Public Health Insurance Act.

It is important to mention in this context that the presumption has an impact in terms of deregulation of the originator price – indeed, the originator price (its maximum year-on-year increase) is not regulated for those groups of medical devices where no negative impact on competition is expected to occur.

However, it is still merely a presumption, and one that is qualified by the phrase “as a rule”, so it is questionable whether it can be safely relied upon in practice.

Just for completeness, we would like to point out that both the previous and the new price regulations assume that the Ministry of Health will issue a price decision setting out a list of medical devices for which the originator price is deregulated. However, no such price decision has been in place since 2019. Price decision 2/13-FAR was in effect until 2019, which explicitly deregulated the manufacturer’s price for, among others, all separately billed material.

It remains the case that price regulation only applies to reimbursed medical devices, whether they are covered by a voucher or as separately billed material. However, medical devices reimbursed as directly consumed medical material (needles, syringes, gloves, etc.) have been excluded from the category of regulated goods.

[1] Explanatory memorandum available here.

[2] Explanatory memorandum available here.