SÚKL · Europe

Czech Republic medical device regulatory resources

Every Czech Republic dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources22/25 topics with recordsOct 2026 fees reviewed

Run the classification agent

Everything we track for Czech Republic

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Czech Republic requirements.

Medical device regulation news

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

AI medical device classifier

Describe your device and get a preliminary SÚKL risk class with official rule references.

Government registration fees

Review current SÚKL application, review, and renewal fees.

Registration timeline

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

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Czech Republic. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Structured regulatory requirements

Explore all 72 source-linked facts →

22 of 25 research dimensions currently covered · 38 official sources · latest verification 2026-10-21

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: SÚKL 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

Check the export certificate against the new identity: For export, the Member State where the manufacturer or authorised representative has its registered place of business shall issue a free sale certificate upon a qualifying request under MDR…
Request a Czech export certificate through ISZP: Czech free sale certificate applications go to SÚKL through ISZP and identify the Basic UDI DI if assigned. One application covers one device or devices of the same generic group. The certi…

9 source-linked facts

Checked 2026-10-21

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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

Keep the responsible manufacturer and device identity consistent: The label identifies the device name or trade name, the manufacturer’s name, registered trade name or trademark and registered business address, and the EU authorised representative where a…
Keep the responsible manufacturer and device identity consistent: The label identifies the device name or trade name, the manufacturer’s name, registered trade name or trademark and registered business address, and the EU authorised representative where a…

5 source-linked facts

Checked 2026-10-21

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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

Unresolved

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 2026-10-21

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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

Retain the exact legacy-change and lawful-stock conditions: For eligible legacy IVDs, organisational/name/address/legal form or AR changes are generally not significant design/intended purpose changes under MDCG 2022 6. Apply amended Article 110 rat…
Retain the exact legacy-change and lawful-stock conditions: For eligible legacy MDs, administrative name/address/legal form changes are generally not significant design/intended purpose changes. The merger/acquisition example requires continuation o…

3 source-linked facts

Checked 2026-10-21

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Lifecycle & post-market

D17

Change control

Verified

Update the actual economic operator and current EUDAMED records: Manufacturers, authorised representatives and importers register their own actor identity in EUDAMED and obtain an SRN where required. Changes to Annex VI Part A actor information are updat…
Document an authorised-representative switch separately: An authorised representative change must be addressed in an agreement between the manufacturer and, where practicable, outgoing and incoming representatives. It covers termination and start…

8 source-linked facts

Checked 2026-10-21

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D18

UDI, listing & traceability

Verified

Map the actual reference, model and UDI change: A commercial REF, order number or catalogue code must first be mapped to the actual device identifier. Annex VI requires a new UDI DI when a change could cause misidentification or ambiguit…
Map the actual reference, model and UDI change: A commercial REF, order number or catalogue code must first be mapped to the actual device identifier. Annex VI requires a new UDI DI when a change could cause misidentification or ambiguit…

4 source-linked facts

Checked 2026-10-21

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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…
SÚKL 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

SÚKL 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

SÚKL 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 SÚKL: 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 SÚKL: 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: SÚKL 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 2026-10-21

Fee line	Amount	Provenance
Custom-made-device manufacturer start-of-activity notification	CZK 3,000	Verified
Distributor start-of-activity notification	CZK 3,000	Verified
Service-person start-of-activity notification	CZK 3,000	Verified
Restoration of invalidated registration data	CZK 1,500	Verified

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 / pathway	Review clock	Planning total	Provenance
Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty	0 days	6-9 months	Verified

Class / pathway

Review clock

Planning total

Provenance

Class I(Self-declaration (no notified body))

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

0 days

6-9 months

Verified