Last year, there was a change in the reporting agenda for distributors and service providers in the Czech Republic. Notification for these entities is conducted in the Medical Devices Information System (ISZP). The data of distributors and service providers who had a valid registration in the Medical Devices Register (RZPRO) at the time of the new system’s launch were migrated to ISZP.
Unlike the RZPRO, in ISZP it is necessary to confirm the validity of the data once a year or submit a notification of a change of the entity (the period is always counted from the last change in the ISZP). If a distributor or service provider has not made any changes in ISZP since the migration date (e.g., has not added or removed distributed medical devices, uploaded new certificates confirming training for performing service, etc.), they must confirm the validity of the data by March 3, 2025.
The State Institute for Drug Control (SÚKL) informed all affected entities via email on February 3, 2025, about the expiration of validity. If the entity does not confirm the validity of the data within 30 days of the notification (i.e., by March 3, 2025), the notified activity will be invalidated.
| SÚKL Notification: Dear Sir/Madam, We would like to inform you that the validity of the reported activity reg. no. XXXXXX will expire in 30 days. According to § 25, paragraph 2 of Act No. 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended, you are required to confirm the validity of the notified data before the above deadline. You can log into the Medical Devices Information System at https://system.iszp.sukl.cz/. |
Please note that if an entity (distributor or service provider) does not have a valid activity in ISZP, they cannot perform distribution or service activities.* As MeDeCorp s.r.o., we have access to ISZP and, upon granting power of attorney, we can assist you with confirming the validity of the data or setting up access to the ISZP system if you do not yet have it.
* This does not apply to distributors and service providers for medical devices of risk class I or class A (according to IVDR), or for in vitro medical devices outside lists A, B, and self-testing (according to the IVD directive).
Our Services
If you need help navigating the complex and evolving legislation on medical devices, do not hesitate to contact us via email at medecorp@medecorp.cz or through the online form on our website www.medecorp.cz. We are also happy to assist you with, for example, placing a medical device on the market, creating technical documentation, or providing comprehensive regulatory affairs support for your company. You can also find a list of our services on our website.