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The State Institute for Drug Control (SÚKL) has launched the Innovation Office for Medical Devices, a new service designed to support innovation in the Czech healthcare sector.
The Innovation Office for Medical Devices will provide expert consultations to entities developing innovative medical devices, in vitro diagnostic medical devices (IVDs), and medical software.
The new service has been established in cooperation with the Ministry of Health as part of broader initiatives aimed at fostering innovation in the healthcare sector and creating a predictable regulatory environment for the development of new medical technologies.
The objective of the Innovation Office is to help developers gain an early understanding of regulatory requirements and identify, at an early stage of their projects, any issues or risks that may affect further product development. Early consultation can contribute to more efficient development planning, an appropriate regulatory strategy, and a smoother route to market.
Expert consultations may cover topics such as the intended purpose of a medical device, its regulatory status, qualification and classification, clinical evaluation or performance evaluation, conformity assessment procedures, and the need to involve a notified body.
At the same time, SÚKL has published the Guidance of the Innovation Office for Medical Devices, which sets out the conditions for submitting applications, the scope of expert consultations, and the procedures for providing them. The guidance also includes a triage form, which serves as the basis for the preliminary assessment of applications and the preparation of expert consultations.
In its initial phase, the Innovation Office is being implemented as a pilot project. Its purpose is to validate the established processes in practice and to gather feedback from both applicants and SÚKL experts. Based on the experience gained during the pilot phase, both the methodology and the scope of consultations may be further refined to better meet the needs of innovators and regulatory practice.
This article is based on information published on the SÚKL website, where the full version is available.
The English translation was prepared using the latest available ChatGPT model.
Reimbursed Medical Devices
A prescription voucher for a reimbursed medical device may only be issued by a treating physician or by a healthcare professional with specialised or special professional qualifications (e.g. a nurse, laboratory technician, therapist, etc.). As of 1 January 2026, the use of an electronic format (eVoucher) has become mandatory for this purpose, subject only to specific exceptions.
On the other hand, the dispensing of medical devices prescribed on a voucher, with subsequent reimbursement claimed from public health insurance, may only be carried out by authorised dispensers. These include pharmacies, medical device dispensing outlets, optical stores, or contracted dispensing providers.
Provision of Medical Devices in a Physician’s Office
As noted above, a person authorised to issue a prescription voucher is not authorised to dispense the prescribed medical device to the patient and subsequently claim reimbursement from public health insurance on the basis of that voucher.
However, certain groups of orthopaedic and prosthetic medical devices (such as orthoses, cervical collars or crutches) are reimbursed when prescribed on a voucher, while their intended purpose also allows their use in the treatment of acute conditions. In such cases, and from the perspective of appropriateness and patient safety, it is permissible for the required medical device to be provided directly to the patient during treatment in the physician’s office.
At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices.
The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers.
The
expected effective date of the amendment is 1 January 2027.
In the following article, we present selected areas of the proposal in relation to specific product categories.
Medicinal Products
The draft expands the definition of advertising, under which all forms of information, market research or incentives intended to promote prescribing, sale, dispensing or consumption will newly be considered advertising.
The amendment also sets out strict conditions under which patient programmes may be conducted so that they are not regarded as impermissible advertising.
Changes will also affect advertising targeted at healthcare professionals. Commercial representatives will newly be allowed to provide Summaries of Product Characteristics (SPC) and reimbursement information also in the form of a link to a source enabling remote access.
Conversely, stricter rules will apply to the provision of free samples, including limits related to the duration of treatment.
The amendment also introduces exemptions from regulation, particularly for incentive programmes run by health insurance funds and for educational programmes aimed at non-physician healthcare professionals.
Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For medical devices and in vitro diagnostic medical devices, the definition of advertising is both expanded and clarified. Advertising will explicitly include, for example, lotteries, similar games, or consumer experience-based testing.
A more precise definition is also introduced for the recipients of comparative advertising, replacing the previously used general term “professionals”.
As with medicinal products, certain exemptions from regulation are defined.
A separate section is dedicated to patient programmes, which aim to improve awareness of diseases, diagnosis and treatment, as well as to support patient cooperation in healthcare provision and to provide training and guidance on the proper use of prescribed medical devices.
Fines
The amendment introduces new obligations and therefore significantly expands the list of actions (administrative offences) subject to penalties.
A fine of up to CZK 500,000 may newly be imposed, for example, for conducting patient programmes in breach of the law—whether due to violation of their intended purpose, content, or the provision of prohibited benefits to patients. The same fine applies to failure to meet notification obligations towards SÚKL, breaches of hospitality rules in online professional meetings, and similar cases.
Fines of up to CZK 2,000,000 are newly expressly applicable to organising prohibited competitions, lotteries and user tests for medicinal products and medical devices, for missing or outdated information in advertising directed at professionals, or for exceeding limits on the number of samples.
Fines of up to CZK 5,000,000 may be imposed for suggesting that the safety of a medicinal product is guaranteed by its natural origin, for using inappropriate depictions of bodily changes, or for providing gifts and benefits to healthcare professionals that are unrelated to their professional activities, among other violations.
Healthcare professionals themselves may newly face fines of up to CZK 100,000 if they actively request prohibited benefits or excessive hospitality, rather than merely accepting them.
Would you like to stay informed about changes in legislation? Feel free to contact us. At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you need expert guidance.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.2.
Pharmeca a.s. provides services within the scope defined by the following legislative framework:
Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended.
Implementing regulations (selected):
Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.
Act No. 280/1992 Coll., on sectoral, professional, company and other health insurance companies, as amended.
Implementing regulations to the Health Insurance Acts (selected):
Act No. 592/1992 Coll., on Premiums for Public Health Insurance, as amended.
Implementing Regulation:
Act No. 526/1990 Coll., on Prices, as amended.
Price regulations / price decisions – Medicinal Products (selected):
Price Decisions – Medical Devices:
Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts, as amended.
Implementing regulation (selected):
Act No 167/1998 Coll, on Addictive Substances and on Amendments to Certain Other Acts, as amended
Implementing regulation (selected):
Act No. 288/2025 Coll., on the Categorisation of Medical Devices Prescribed on Vouchers Reimbursed from Public Health Insurance and on Amendments to Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts (the Medical Devices Categorisation Act), as amended
Act No. 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.
Implementing regulation (selected):
Act No 376/2022 Coll., amending certain Acts in connection with the adoption of the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.
Act No. 268/2014 Coll., In Vitro Diagnostic Medical Devices, as amended.
Act No. 89/2021 Coll., on Medical Devices and on Amendments to Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended.
Implementing regulation:
Act No. 22/1997 Coll., on Technical Requirements for Products and on Amendments to Certain Related Acts, as amended.
Act No. 90/2016 Coll., on Conformity Assessment of Specified Products when Supplied on the Market, as amended.
Act No. 325/2021 Coll., on Healthcare Digitalisation, as amended, and other related acts, as amended
Act No. 372/2011 Coll., on Health Services and Conditions for Their Provision (the Health Services Act), as amended.
Implementing regulations (selected):
Act No. 40/1995 Coll., on Regulation of Advertising and on Amendments to Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended.
Act No 242/2022 Coll., on Video-sharing Platform Services and on Amendments to Certain Related Acts (the Video-Sharing Platform Services Act), as amended.
Act No. 387/2024 Coll., on General Product Safety and on Amendments to Certain Related Acts, as amended.
Act No. 500/2004 Coll., the Administrative Procedure Code, as amended.
Current price decisions, opinions and methodological gudelines or regulations of the Ministry of Health of the Czech Republic.
Instructions and guidelines of SÚKL.
In connection with the new Act No. 288/2025 Coll., on the categorization of medical devices prescribed on voucher and reimbursed from public health insurance, and on the amendment of Act No. 48/1997 Coll., on public health insurance and on the amendment and supplementation of certain related acts, as amended, the State Institute for Drug Control (SÚKL) has published a set of questions and answers.
The following text highlights selected points that focus not only on the new obligations for the entities concerned.
Is it possible to submit a notification of an annual increase in the manufacturer’s price already in November, effective from 1 January 2026?
Yes. Under the currently valid price regulation, an annual increase in the manufacturer’s price may be submitted from 1 November 2025. These notifications are processed into lists published in December, effective from 1 January 2026.
Will the change of reimbursement group be carried out automatically based on the current classification of the medical device, or must the authorization holder (manufacturer/authorized representative) actively submit a new notification in the ISZP system?
The Institute cannot automatically reclassify products into a newly established reimbursement group. It is necessary to submit a notification of the change of the reimbursement group (UHS) pursuant to Section 39s(7) of the Act on Public Health Insurance, as amended and effective from 1 January 2026.
When and how will it be possible to notify a change in the reimbursement group according to the new Act on the Categorization of Medical Devices?
The change of the reimbursement group must be submitted between 1 January 2026 and 31 January 2026 via the ISZP system.
Which date is decisive for assessing the reimbursement amount and the correct classification of a medical device – the date of the voucher being issued by the physician or the date of actual dispensing of the medical device by the pharmacy/distributor?
If a medical device is prescribed under the Act on Public Health Insurance (ZoVZP) and redeemed before the new Act on the Categorization of Medical Devices (ZoKaZP) takes effect, it is reimbursed under the original conditions of ZoVZP (see Section 3(1) of ZoKaZP).
If the device is prescribed under ZoVZP but redeemed after ZoKaZP takes effect, it is reimbursed under the new conditions of ZoKaZP (see Section 3(2) of ZoKaZP).
In the case of a voucher issued by 30 April 2026 for an elastoviscous solution in reimbursement group UHS 11 — i.e. for a medical device reimbursed under the transitional provisions of Section 3(4) of ZoKaZP — and if the voucher is redeemed (the patient collects it) in the following month (May 2026), such a medical device is reimbursed under the conditions of UHS 07.07.01.01 ZoKaZP.
Can an existing power of attorney still be recognized if it does not include the newly established reimbursement group 07.07.01.01, provided it is clear from its content that it applies to the categorization and reimbursement of medical devices in general?
If the power of attorney covers all medical devices of a manufacturer, it may continue to be used as an approved valid authorization. However, if the power of attorney lists specific reimbursement groups or specific medical devices and does not include the new reimbursement group or the related devices, it cannot be used for medical devices in the new reimbursement group.
Is it possible to submit an application now using the existing power of attorney, and later provide an updated version including the new group (for example, as an amendment to the power of attorney) after it is issued?
SÚKL does not and has not accepted any amendments, supplements, or declarations to existing powers of attorney. In assessing powers of attorney, the Institute must act consistently for both medicinal products and medical devices.
Do you recommend any alternative formal way to ensure timely submission of the application during the period when the new reimbursement group is not yet included in the issued authorization or in public lists?
If the new reimbursement group is not included in the approved power of attorney, it is necessary to submit a new application with a new power of attorney containing the respective group or devices, or a power of attorney covering all the manufacturer’s medical devices.
Please note that if several powers of attorney are submitted for all medical devices of the same manufacturer, a problem may arise where previous powers of attorney for other representatives of the same manufacturer will be terminated due to multiple authorizations. Therefore, if you represent only certain medical devices of a manufacturer, please carefully consider the scope of your power of attorney.
In case of any uncertainties or other questions regarding powers of attorney, please use the email address plne_moci@sukl.gov.cz, or consult your company’s legal representative.
The complete article is available on the SÚKL website.
Do you need to request an annual increase in the manufacturer’s price or advice on how to submit a notification through ISZP? Contact us.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.
VZP has again extended the deadline for submitting the Proposal to Enter EMDN Codes (European Medical Device Nomenclature) for medical devices listed in the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) until 31 December 2025. For this purpose, VZP has published the application template: “2.I Návrh na vložení EMDN pro ZUM v ÚK VZP – ZP – VZP ČR”.
In response to requests from applicants (manufacturers/suppliers of ZUM) whose devices are listed in the ÚK VZP – ZP, VZP has also published a list of VZP codes for which, as of 7 October 2025, it records terminal EMDN branches; see List of ZUM with a Terminal EMDN Branch.
At the same time, VZP notes that the proposal “2.CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP” has also been published for non-traded items for which no EMDN category has been provided.
After the above deadline, VZP will assign an EMDN code to any ZUM for which no EMDN category has been submitted.
The text was translated using ChatGPT 5.
VZP informs applicants about the option to keep non-traded medical devices without EMDN in the Reimbursement Catalogue.
As part of the ongoing refinement of the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) and following a request from the Ministry of Health in connection with forthcoming legislation, all medical devices that were included in the ÚK VZP – ZP (ZUM) by 31 December 2023 and that, according to VZP ČR and SZP ČR data, were not traded (no recorded sales) between 1 January 2024 and 30 June 2025, and for which no EMDN category was submitted by 31 August 2025, and for which VZP ČR does not receive the relevant proposal, will be removed from the ÚK VZP – ZP (ZUM) as of 1 March 2026.
VZP hereby informs applicants of the possibility to keep non-traded ZUMs without EMDN in the Reimbursement Catalogue.
Applicants may, by 31 December 2025, submit the proposal “2. CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP – VZP ČR” (Proposal to Retain Non-Traded medical devices in the ÚK VZP – ZP – VZP ČR) if they wish to keep non-traded medical devices without EMDN in the catalogue.
If the proposal is not submitted or is rejected, the ZUMs concerned will be removed from the ÚK VZP – ZP.
List of non-traded medical devices
The text of the opinion was translated using ChatGPT 5.
VZP is requesting that all applicants submit EMDN codes (European Medical Device Nomenclature) for all medical devices (ZÚM) listed in the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) by 30 June 2025.
This requirement follows a request from the Ministry of Health in connection with forthcoming legislation. The inclusion of EMDN codes, in accordance with Article 26 of the MDR / Article 23 of the IVDR, is essential for setting clear, transparent, and predictable rules, both within the legislative process and for the inclusion, modification, or price/reimbursement adjustment of medical devices in the ÚK VZP – ZP.
According to the current wording of the MDR / IVDR, manufacturers must assign an EMDN code to their device, which will be used for registration in the EUDAMED database and linked to the device’s Unique Device Identifier (UDI-DI).
Using the EMDN hierarchical structure, manufacturers must always assign the code at the lowest applicable level available (i.e., the most specific level of the categorisation tree).
If one ZÚM item includes multiple devices (catalogue numbers) with different EMDN codes, list each EMDN code in the corresponding “EMDN” column.
If a single device (catalogue number) has multiple intended purposes and therefore multiple potential EMDN codes, select and submit only one EMDN code.
A single submission may contain up to 5,000 ZÚM items.
The template and submission instructions are available on the VZP website.
The text of the opinion was translated using ChatGPT 4o.
