MDCG Opinion 2026-5 on UDI assignment between manufacturers and distributors
Publication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech Republic
Source
Czechia SUKL
Regulation
Category
Type · Breadth
Date
Handling of medical devices intended for direct patient payment, not from public health insurance funds – Information update 8 June 2026
Guidance on handling medical devices in outpatient care settings when paid directly by patients rather than through public health insurance.
Czechia SUKL · Czech RepublicFree Sales Certificate applications via ISZP only from 1 September 2026
From 1 September 2026, Free Sales Certificate applications must be submitted exclusively through ISZP (Medical Device Information System), not RZPRO (Medical Device Register).
Czechia SUKL · Czech RepublicChange in procedure for submitting Free Sale Certificate (FSC) applications
From 10 August 2026, Free Sale Certificate applications will be submitted through the Medical Devices Information System (ISZP).
Czechia SUKL · Czech RepublicCzech patients can now collect medicines prescribed on Czech e-Prescription in Austrian pharmacies
From 5 August 2026, Czech e-Prescriptions can be redeemed in Austrian pharmacies, expanding cross-border electronic prescribing interoperability.
Czechia SUKL · Czech RepublicSeminar No. 16 – Medical Devices Control Department: Medical devices in daily healthcare facility practice
TÉMA: Zdravotnické prostředky v každodenní praxi zdravotnického zařízení | Datum konání: 3. 11. 2026 9:00–15:00 | prezenčně – opakování semináře z roku 2026, který je určený poskytovatelům <b style="color: #...
Czechia SUKL · Czech RepublicSeminar No. 15 – Medical Devices Control Department: Obligations of distributors and importers of medical devices
TÉMA: Povinnosti distributorů a dovozců zdravotnických prostředků | OPAKOVÁNÍ semináře z 22. 1. 2026 | Datum konání: 8. 10. 2026 9:00–12:30 | prezenčně
Czechia SUKL · Czech RepublicSeminar No. 14 – Medical Devices Control Department: 3D printing in hospital environments
TÉMA: 3D tisk v prostředí nemocnic – workshop pořádaný ve spolupráci SÚKL a České společnosti pro 3D tisk v medicíně | Datum konání: 12. 11. 2026 9:00–15:00 | prezenčně
Czechia SUKL · Czech RepublicSeminar No. 13 – Medical Devices Control Department: Medical devices in daily practice of healthcare facilities
TÉMA: Zdravotnické prostředky v každodenní praxi zdravotnického zařízení | Datum konání: 8. 9. 2026 9:00–15:00 | prezenčně – opakování semináře z roku 2026, který je určený poskytovatelům <b style="color: #F...
Czechia SUKL · Czech RepublicCzech Ministry of Health presents first National Strategy for Clinical Trials and planned information portal for patients and professionals
Czech Ministry of Health adopted the first National Strategy for Clinical Trials of Human Medicinal Products 2035, aiming to improve research conditions and patient access to innovative therapies.
Czechia SUKL · Czech Republic
Showing 10 of 10 tracked updates
— health-tech relevant only. Show all health policy