Drug database
Registration and Notification
REPORTING OBLIGATIONS
The current Czech legislation in the area of medical devices and in vitro diagnostic medical devices is based on Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended (hereinafter referred to as the “Act on Medical Devices”). This Act is an adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
Pursuant to the transitional provisions of Section 74(7) and (8) of Act on Medical Devices, the Registry of Medical Devices (hereinafter referred to as “RZPRO”) shall continue to be used to meet the obligations of manufacturers, authorised representatives and importers to notify SÚKL of their operations, until the fully operational EUDAMED is launched. The same applies to the notification of medical devices. The processes are set up according to the original legislation. The validity of an operation / medical device notification is granted for a period of 5 years, and a notification of renewal must be submitted before the expiry of this period.
Instructions on how to use the RZPRO can be found here: Manuals RZPRO – SÚKL.
Distributors, persons servicing medical devices and manufacturers of custom-made medical devices are obliged to notify SÚKL via the Medical Device Information System – SÚKL (hereinafter referred to as „ISZP“) before commencing their operations, in accordance with Sections 8 and 23 of Act on Medical Devices. This obligation shall not apply to a distributor who supplies exclusively risk class I medical devices or risk class A in vitro diagnostic medical devices or who supplies devices exclusively to a user who is not a healthcare provider. Nor is it mandatory to a person servicing exclusively risk class I medical devices or risk class A in vitro diagnostic medical devices.
If you are a manufacturer established outside the territory of the Czech Republic in the EU and supply your devices directly to the Czech market, you are not subject to the obligation to notify your operation.
The manufacturer shall provide device data to EUDAMED before placing the device on the market in compliance with Article 31 MDR/IVDR.
To notify an operation to the ISZP, use the “New notification of an operation” function, the procedure described in the video manual Person Module – Instructions for notifying Distributor operation in ISZP System . As part of the notification, it is necessary to submit a list of the medical devices you supply to the market. For each medical device, its name, intended purpose, risk class, basic UDI-DI (if assigned) must be provided.
Instructions on how to use the ISZP can be found here: Medical Device Information System – SÚKL
As an importer, manufacturer and/or an authorised representative I am registered in EUDAMED. Do I also need to be registered in RZPRO?
Yes, you are required to do so. According to Section 74 (7) and (8) of Act on Medical Devices, „Until the full functionality of the persons module in the EUDAMED database, persons shall register via the RZPRO established by Act No 268/2014 Coll. in the version effective prior to the date of entry into force hereof“. It follows from the aforementioned, that until the fully functional EUDAMED is launched, registration in it is exclusively on a voluntary basis, while registration at the national level in the RZPRO is mandatory for all entities subject to legal obligations.
If I am a manufacturer of custom-made devices established outside the Czech Republic, am I subject to the reporting obligation?
In this case, it very much depends on whether the definition of a custom-made device is met (“custom-made device” means a device specifically made according to a written instruction by any person authorised by national law through their professional qualifications, which leads to specific design characteristics unique to that device and provided under that person’s responsibility. Such a device is intended for the sole use of a particular patient and exclusively to meet their individual conditions and needs”. However, mass-produced devices that are adapted to meet the specific requirements of any professional user are not considered to be custom-made devices. This includes adapted versions of devices that are mass-produced through industrial manufacturing processes, according to written instructions by an authorised person).
In case the products do not meet the aforementioned definition, but are mass-produced medical devices, it is necessary to register the operation of a distributor in the ISZP system and to declare all such medical devices that will be supplied to the Czech market.