Registration and Notification
Medical Device National Information System (ISZP)
Medical Devices Section informs about the launch of the Medical Device National Information System (hereinafter referred to as „ISZP“) pursuant to provisions of Section 7 of the Act No 375/2022 Coll., on medical devices and on in vitro diagnostic medical devices, as amended (hereinafter referred to as the „Act on Medical Devices“).
ISZP is currently being used to execute the following agendas in the area of medical device regulateion:
Notification of persons – pursuant to Section 8 and Section 23 of the Act on Medical Devices
Ethics Committees - pursuant to Section 13 of the Act on Medical Devices
Other clinical investigations - pursuant to Section 22 of the Act on Medical Devices
Repackaging / relabelling - pursuant to Section 7(4) of the Act on Medical Devices
Reimbursement – pursuant to Part 7 of the Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Additions to Certain Related Acts, as amended.
You can log in to the ISZP here
Access to the ISZP
You must first apply for access to the ISZP via the External Identity Portal
Instructions on how to apply can be found here.
In case you are not the applicant's legal representative, please upload a signed authorisation (scan of a manually signed authorisation or pdf signed with a qualified electronic signature).
Authorisation of a staff member to set up access to the ISZP
Grant of power of attorney to perform acts in the ISZP
The granting of a power of attorney to perform acts in the ISZP will only be possible via an electronic form in the ISZP interface.
The process of launching a request for authorisation of a power of attorney can be initiated provided that the entities involved in the process have set up an account on the external identity portal through which you apply for access to the ISZP and also set up user accounts, see Access to the ISZP.
Provided that the above is met, the application for authorisation of a power of attorney in the ISZP can be launched. This process depends on how you log in to the ISZP.
For a description of each situation, please go to Přidělení plné moci v Informačním systému zdravotnických prostředků (ISZP) | NISZP
RZPRO – agendas provisionally processed via RZPRO
Due to the delayed launch of the fully operational EUDAMED database, the RZPRO will continue to be used for the following scope of activities.
This will apply to:
- Notifications of manufacturers, importers and authorised representatives
- Registration of medical device by manufacturers, importers and authorized representatives
- Clinical investigations and monitoring-related agenda (except for other clinical investigations pursuant to Article 82 of the MDR)
- Agenda related to the authorisation and monitoring of performance studies.
- Application for free sale certificates
- Field safety notice
Procedure to be used by distributors and persons servicing devices
Pursuant to Section 25 of the Act on Medical Devices, the notified person is obliged to confirm the accuracy of the notified data within the timeline of 1 year starting from the date of notification pursuant to Section 23 of the Act on Medical Devices. This functionality will be made available in the ISZP 60 days before the expiry of the 1-year period as of the launch of the ISZP, when the Confirmation of Accuracy button appears in the profile. Within 30 days prior to the expiry of the timeline specified in sentence one, the Institute shall send, via the ISZP, a reminder of the necessity to confirm the accuracy of the notified data to the notified person.
Until then, you can only notify changes to your data. Once the change notification has been successfully processed, the expiry date will be extended for one year.
If you discover an error in the migrated data or if there is a change to the portfolio of medical devices supplied or manufacturers serviced, submit a notification of a change of operation. Confirmation of Accuracy will only be used in case there has been no change to the details of an operation for 10 months.
The validity of all actors´ activities is currently set to one year.
Procedure to be used by custom-made device manufacturers
Pursuant to Section 8(4) of the Act on Devices, the manufacturer is obliged to provide the State Institute for Drug Control (hereinafter referred to as “Institute”):
- with information on the commencement of operation within 30 days of the commencement of manufacture of the custom-made device
- with a list of generic groups of manufactured devices within 6 months of the manufacture commencement
- information on cessation of operation.
Following the migration of data, the Institute recommends that manufacturers of custom-made devices apply for access to the ISZP and check their data in the system, or, within one year, submit a change notification to notify the generic group according to the European Medical Device Nomenclature (EMDN). The EMDN is uploaded directly in the ISZP in the notification wizard.
The Institute further recommends that manufacturers make themselves familiar with the nomenclature codes they will enter in the notification, before actually submitting a notification.
More detailed information on the nomenclature can be found on the European Commission's EMDN codes website (europa.eu). The nomenclature is established in a seven-level hierarchical tree. The Institute requests the addition of the lowest applicable level for devices that are placed on the market.
The EMDN is available directly here European Medical Device Nomenclature (EMDN) (europa.eu)
Further additional MDCG Guidance on EMDN can be found at Guidance - MDCG endorsed documents and other guidance - European Commission (europa.eu)
MODULE REIMBURSEMENT - PROCESSES