Czech SÚKL Moves Free-Sale Certificate Filing to ISZP

The Czech State Institute for Drug Control (SÚKL) will accept applications for certificates of free sale (FSC; certifikát o volném prodeji) through the Register of Medical Devices (RZPRO) only through 31 August 2026. From 1 September 2026, new applications may be filed only through the Medical Device Information System (ISZP).

SÚKL said so in a 24 August 2026 notice and set out the current conditions on its FSC page. The audience is manufacturers and authorised representatives that request a Czech FSC.

SÚKL states that the move follows § 10 of Act No. 375/2022 Sb. on medical devices and IVDs. This is an administrative filing change communicated by SÚKL, not a new statute.

Transition that is already running

A 5 August 2026 notice opened ISZP filing from 10 August 2026 and runs a dual window through 31 August 2026 (ISZP or RZPRO). At the end of August the medical-device module in RZPRO will be deactivated. The same notice states that applications submitted in RZPRO by 31 August 2026 will still be processed after that deactivation.

From 1 September 2026 there is no RZPRO filing route for a new FSC request.

Conditions in ISZP

The FSC page makes two filing conditions in one sentence: the device must be registered in EUDAMED in status “Registered” (data publicly available), and the administrative fee of 1,000 CZK must be paid.

The 5 August notice adds that devices still in EUDAMED status “Submitted” cannot be selected in an ISZP FSC application. SÚKL’s recommendation in that notice is to contact the notified body promptly so that the CE certificate is uploaded and the record can move to “Registered.”

SÚKL states that ISZP draws device data from EUDAMED, and that the relevant EUDAMED modules have been in mandatory use since 28 May 2026. Data in RZPRO will not be updated further and will not be transferred into ISZP or EUDAMED.

Under § 10(6) of Act No. 375/2022 Sb., as restated by SÚKL, an application may cover:

• a single device at basic UDI-DI level; or
• a group of devices in the same generic group.

Documents SÚKL lists for the file

SÚKL's live FSC page requires the following core attachments for class I medical devices and class A IVDs, and for devices where no notified-body certificate is registered in EUDAMED:

• instructions for use (IFU);
• the EU declaration of conformity under the MDR or the IVDR;
• a clinical evaluation report (CER) or a performance evaluation report (PER).

ZP-27 version 1 has been valid since 28 May 2026 and describes itself as recommendatory guidance. Its documentation section is broader and differently framed: it covers class I medical devices, class A, B and C IVDs for which a notified body does not participate in conformity assessment, and MDR legacy devices. For those files it lists the same core documentation: IFU, EU declaration of conformity, and final CER or PER.

The live FSC page and ZP-27 therefore do not describe the affected attachment population in identical terms. Applicants should not use either summary to narrow a file without checking the current ISZP checklist for the specific device.

For devices on the market under MDR Article 120 (legacy devices), the applicant must also submit documentation under the previous directives and evidence of the transitional conditions in Regulation (EU) 2023/607. SÚKL names in particular:

• a valid notified-body certificate under Directive 93/42/EEC or 90/385/EEC;
• the notified body’s confirmation letter that the transitional conditions are met.

SÚKL may, before issuing an FSC, verify that nothing has changed that would prevent issue (§ 10(3) as cited on the FSC page) and may require further device documentation. It also recalls the manufacturer’s duty under MDR Article 10(8) / IVDR Article 10(7), and the authorised representative’s duty under Article 11(3)(d) of both regulations, to provide complete technical documentation on request.

What SÚKL says is not changing

The FSC page states that SÚKL is not currently preparing a change to the rules on how many devices may be included in one FSC, or to the required particulars of the certificate itself.

Those particulars follow MDR Article 60 / IVDR Article 55: the basic UDI-DI of the device registered in EUDAMED, and, where a notified body has issued a certificate under MDR Article 56 / IVDR Article 51, that certificate’s unique number.

The manufacturer remains responsible for the accuracy, completeness and currency of the file and for conformity with the MDR, the IVDR, and Act No. 375/2022 Sb.

What applicants should do before the cutover

1. If an FSC is needed immediately and the device is already “Registered” in EUDAMED, file in ISZP now, or in RZPRO no later than 31 August 2026 if that route is still open for that file. SÚKL’s 5 August notice states that RZPRO filings made by that date will still be processed; new filings after 31 August cannot use RZPRO.
2. If the EUDAMED record is still “Submitted”, it cannot be selected in ISZP. Resolve the CE-certificate upload with the notified body before relying on ISZP.
3. Do not assume RZPRO history will appear in ISZP. It will not migrate.
4. Budget 1,000 CZK and check the device-specific ISZP checklist against both the live FSC page and ZP-27. Do not assume the core IFU, EU DoC, and final CER/PER set is limited to class I devices and class A IVDs. Legacy Article 120 files also need the prior-directive certificate and confirmation letter.
5. Do not expect a change in how many devices sit on one certificate unless SÚKL later says otherwise; the FSC page says no such change is in preparation.

SÚKL’s process page is the FSC information page. EUDAMED operator and device registration more generally is described in Pure Global’s EUDAMED glossary and in the update on MDCG 2026-4.