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SÚKL · Europe

Czech Republic medical device regulatory resources

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5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent State Institute for Drug Control (SĂšKL) policy, guidance, safety, and compliance updates.

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Government registration fees

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Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 58 source-linked facts →

23 of 25 research dimensions currently covered · 28 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
State Institute for Drug Control (SÚKL) is the competent authority for medical devices and IVDs: it supervises persons handling devices, imposes fines by decision, authorises clinical inves…
State administration bodies for devices
State administration in the devices area is exercised by the Ministry of Health (Ministerstvo zdravotnictví), the State Institute for Drug Control (SÚKL, 'Ústav'), and the Czech Office for…
3 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Implementing decree
Decree No. 377/2022 Sb. implements certain provisions of Act No. 375/2022 Sb. (issued by the Ministry of Health under the empowering clause § 68 of the Act; e.g. content of documentation of…
National implementing act
Act No. 375/2022 Coll., on medical devices and in vitro diagnostic devices, is the national law implementing MDR/IVDR, effective 22 December 2022 (replacing Act No. 268/2014 Coll. as the de…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Borderline and definition determinations
SĂšKL decides whether a product is a medical device and determines its classification (borderline determinations), alongside registering devices in the national register.
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
Custom-made manufacturer notification via ISZP
A custom made device manufacturer seated in the Czech Republic must provide to SÚKL via ISZP: information on start of activity within 30 days of starting production, a list of generic devic…
Transitional device notification via RZPRO
Until the EUDAMED device module is fully functional, medical devices and IVDs are notified through the Register of Medical Devices (RZPRO) established by the former Act No. 268/2014 Sb. (as…
7 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:cze · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
3 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Distributor notification content (basic UDI-DI)
A distributor's ISZP notification must include, for devices other than class I / class A IVDs intended to be placed on the Czech market: the basic UDI DI of the device model in the UDI syst…
Service-person notification content
A service person's ISZP notification must include the list of unique registration numbers of the manufacturers for whom servicing is intended, and a copy of the training certificate per § 4…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
No device use within ordinary trade licence
Ministry of Health position (statement of 14 August 2025): a medical device cannot be used within the scope of an ordinary trade licence business (živnost) — e.g. teeth whitening services w…
Provider duties extended to non-health services
Obligations for device use in healthcare (parts seven, eight and nine of Act 375/2022 Sb.: use, servicing, vigilance) apply analogously to persons providing services other than health servi…
4 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Conformity documentation languages (CZ/SK/EN)
A manufacturer or authorised representative seated in the Czech Republic, or placing devices on the Czech market, must keep and submit to SÚKL on request all information and documentation n…
Ethics committee submissions in Czech
Documents required by the ethics committee for a clinical investigation or performance study must be submitted in Czech; the committee may allow another language, except for the informed co…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
ISZP agendas and access
The ISZP portal carries the agendas: Persons (§§ 8 and 23 of the Act), Ethics committees (§ 13), Other clinical trials (§ 22, MDR Art. 82), Repackaging/relabeling (§ 7(4)), and Reimbursemen…
ISZP statutory basis and operator
SÚKL is the founder, administrator and operator of the Information System of Medical Devices (ISZP), a public administration information system for collecting and managing data and for fili…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Distributor must supply Czech IFU
A distributor distributing a device to the Czech market must supply the device including the instructions for use in Czech, where the manufacturer has issued an IFU.
Manufacturer Czech-language information duties
A manufacturer placing devices on the Czech market must provide in Czech the information under MDR Art. 10(11) / IVDR Art. 10(10), the information under MDR Art. 18(1)(a) (d), the informati…
3 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Periodic safety-technical check frequency
Periodic safety technical checks (bezpečnostně technická kontrola, BTK) of devices in use are performed in the scope and frequency set by the manufacturer; if the manufacturer sets no frequ…
BTK reserved to qualified professions
The safety technical check of an active class IIa device, of class IIb and III devices, and of IVDs may be performed exclusively by a professional qualified as biomedical technician, biomed…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
Nařízení vlády 426/2016 radio equipment conformity
Wireless / radio
7 maintained overlays · 1 related fact
Checked 2026-08-25
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D14

Fees

Verified
Custom-made-device manufacturer start-of-activity notification
CZK 3,000
Distributor start-of-activity notification
CZK 3,000
7 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
ISZP notification validity and annual confirmation
Notified activity data in ISZP are valid for 1 year: the notified person must confirm the correctness of its data within 1 year of notification or of the last confirmation; SÚKL sends a rem…
1 source-linked fact
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Substantial changes to Art. 82 trials via ISZP
Since 7 March 2024, notifications of MDR Art. 82 other clinical trials, applications for substantial modifications of such trials, and reports of serious adverse events during them are subm…
Change notification within 30 days
A notified person must report a change of its § 23 notification data via ISZP within 30 days of the change; the change notification counts as confirmation of the correctness of all other no…
2 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Basic UDI-DI in FSC applications
A free sale certificate application must include the basic UDI DI of the device model in the UDI system (MDR Art. 27 / IVDR Art. 24), where one has been assigned, and state whether an elect…
Provider UDI retention and use records
A healthcare provider must retain the unique identification (UDI) of devices supplied to it, except class I devices and class A IVDs, and present this information to SÚKL on request. Where…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigation applications via RZPRO (transitional)
Until the EUDAMED clinical trials module is fully functional, applications for clinical investigation authorisation under MDR Art. 62 and Art. 74(1) (2) are submitted through the Register o…
Art. 82 trial notification 60 days in advance
The sponsor of an MDR Art. 82 other clinical trial must file with SÚKL via ISZP, 60 days before starting, a notification of intent including Annex XV chapter II documentation (points 1, 2,…
4 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
MoH exemption for individual patient use
The Ministry of Health may, on a healthcare provider's application, authorise putting into service a device for which conformity assessment procedures were not carried out, where (a) use is…
SĂšKL exemption for public-health interest
SÚKL may, on application by the manufacturer, authorised representative or importer, authorise the placing on the Czech market, putting into service and use of a specific device that did no…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
SĂšKL assessment of trend reports
SÚKL assesses manufacturers' trend reports under MDR Art. 88(1) / IVDR Art. 83(1); where the assessment indicates a risk to patients, users, other persons or public health, SÚKL calls on th…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
SĂšKL incident-record retention periods
SÚKL retains all information on serious incidents in the Czech Republic and on field safety corrective measures for 15 years; where a serious incident involved injury or death of a user, pa…
Manufacturer MIR forms (Czech/English)
SÚKL publishes manufacturer incident report forms (MIR) for MDR/IVDR serious adverse events: initial report, follow up report, combined initial and final report, final report (reportable ev…
4 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Field safety notice publication by SĂšKL
SÚKL publishes, via ISZP, field safety notices (FSN) sent by the manufacturer, authorised representative or distributor to users in connection with an FSCA carried out or to be carried out…
FSCA report format and channels
Manufacturers report field safety corrective actions (FSCA) to SÚKL by an electronically filled form signed with a recognised electronic signature (based on MEDDEV Field Safety Corrective A…
3 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising supervision by SĂšKL
Advertising of medical devices and IVDs within SÚKL's competence is regulated by Act No. 40/1995 Sb. on advertising regulation, Act No. 375/2022 Sb. and Decree No. 377/2022 Sb.; supervision…
Professional-audience advertising restrictions and fines
Disseminating, via communication media, advertising for devices or IVDs aimed at professionals where the media are not predominantly intended for professionals is an offence punishable by a…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
No suspensive effect of appeal against preventive measures
SĂšKL issues a decision on preventive (safeguard) measures under MDR Art. 98 / IVDR Art. 93; an appeal against this decision has no suspensive effect.
1 source-linked fact
Checked 2026-08-25
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Government fees

Full fee schedule (7 lines) →

SÚKL registration fees in CZK · reviewed 2026-08-25

Fee lineAmountProvenance
Custom-made-device manufacturer start-of-activity notificationCZK 3,000Verified
Distributor start-of-activity notificationCZK 3,000Verified
Service-person start-of-activity notificationCZK 3,000Verified
Restoration of invalidated registration dataCZK 1,500Verified
3 more fee lines on the full schedule · 7 of 7 rows source-verified

Registration timeline

Full registration timeline →

State Institute for Drug Control (SÚKL) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

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Newest official SÚKL headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 24SIState Institute for Drug Control (SĂšKL)SĂšKL Publishes Guidance on Certificates of Free Sale (FSC) Applications for Medical DevicesCzech Republic
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