Participant registration
On the 8th floor in front of the PANORÁMA hall on Monday, 14 December 2026, from 13:00 to 17:00.
International Conference
MDR / IVDR QUALITY DAYS 2026
231
days
14
hours
37
minutes
52
seconds
Programme
Conference programme
Dress code
Semi formal
Catering during the conference
On 14 December 2026, catering begins with lunch from 12:00 to 15:00.
Restaurant on the 7th floor: breakfast 7:00 - 10:00, lunch 12:00 - 15:00, dinner 18:00 - 21:00.
Monday
14.12.2026
Lunch in the restaurant with a panoramic view of the High and Low Tatras, 7th floor
Participant registration on the 8th floor, in front of the PANORÁMA hall
Dinner in the restaurant with a panoramic view of the High and Low Tatras, 7th floor
Gala Evening with a Live Performance by FRAGILE and the Art Music Orchestra
Festive opening speech - Ing. Katarína Tomin Srdošová, PhD. - Director of Notified Body No. 2265, Chairwoman of the Board of 3EC International a. s.
The opening, Company Introduction
Katarína Tomin Srdošová
Incoming changes in MDR
Ján Slúka
Incoming changes in IVDR
Janka Šepeláková
Transitional period MDR (Annex XVI) and IVDR
Michal Tomin
Coffee break
Certification process MDR / IVDR
Zuzana Maslíková
EUDAMED
Eva Rýdlová
MDSAP
Mark Tomin
Lunch Break, 7th floor
Understanding the TD - Key to Success
Juraj Šalgovič
Open Discussion
Information to be Supplied by the Manufacturer, Labelling & IFU
Janka Šepeláková, Slavomír Damin and Juraj Gašparovič
Product Verification and Validation, Pre-clinical and Clinical Data / Biocompatibility, Devices Incorporating Medicinal and Biological Materials, CA approvals
Ján Slúka
Packaging, Stability and Shelf-Life
Slavomír Damin and Janka Šepeláková
Coffee break
Benefit-Risk Analysis and Risk Management, Usability
Karol Jedlovský
Performance evaluation under IVDR
Juraj Gašparovič and Janka Šepeláková
Lunch Break, 7th floor
Clinical evaluation under MDR & PMS
Juraj Šalgovič, Daniela Král and Michal Hronský
MDR / IVDR “SW KARAT”
Tomáš Polák
Closing remarks and Open Discussion
Breakfast at the restaurant, 7th floor
Room Check-out
Wellness access available until 16:00
Speakers
Meet our experts
Ing. Katarína Tomin Srdošová, PhD.
Director of NB 2265, Chairwoman of the Board 3EC International a. s.
Ján Slúka
MDR Manager
Janka Šepeláková
IVDR Manager, Project Manager
Michal Tomin
Deputy Director of NB 2265
Zuzana Maslíková
Deputy Quality Manager, Project Manager
Eva Rýdlová
Back Office & Client Support, EUDAMED
Mark Tomin
Quality Manager
Juraj Šalgovič
MDR / IVDR Clinical Evaluation Manager, Project Manager
Slavomír Damin
Technical Documentation, Packaging and Sterilization Expert
RNDr. Juraj Gašparovič, PhD.
Auditor at 3EC International a. s., NB 2265
K
Karol Jedlovský
Risk Management and Medical Device Certification Expert
Daniela Král
MDR Clinical Evaluation and PMS Expert
M
Michal Hronský
MDR Clinical Evaluation and PMS Expert
Tomáš Polák
IS Karat Admin
Transport
How to get to the conference
Most participants will arrive independently. An airport transfer is available for arrivals by plane, and a hotel transfer is available from Liptovsky Mikulas railway station for arrivals by train.
Free parking
Own transport
If you arrive by car, free parking is provided as part of the accommodation directly at the hotel.
- Grand hotel Permon****, Podbanske, High Tatras
179 EUR incl. VAT
Airport transfer
Organized air-conditioned bus transfer from Vienna-Schwechat Airport via Bratislava to Grand hotel Permon**** and back.
- 14 Dec 2026: VIE [AT] > BA [SK] > Permon [SK]
- 17 Dec 2026: Permon [SK] > BA [SK] > VIE [AT]
Free of charge
Hotel transfer
For participants arriving by train, a hotel minibus or car will be available at Liptovsky Mikulas railway station.
- 14 Dec 2026 at 14:30: Liptovsky Mikulas rail station [SK] > Permon [SK]
- 17 Dec 2026 from 8:00: Permon [SK] > Liptovsky Mikulas rail station [SK]
Planned route
-
14 Dec 2026: VIE [AT] > BA [SK] > Permon [SK]
-
17 Dec 2026: Permon [SK] > BA [SK] > VIE [AT]
Accommodation
Accommodation directly at Grand hotel Permon****
Accommodation is paid directly to the hotel at the conference venue. Reservation must be made in writing by e-mail to kongres@hotelpermon.sk.
Reserve accommodationincl. VAT / 1 night
480 EUR / 3 nightsincl. VAT / 1 night
600 EUR / 3 nightsThe accommodation price includes breakfast, in-room slippers, free swimming in the pool area from 7:00 to 10:00 and parking.
The price does not include accommodation tax: EUR 0.80 / person / day.
Venue
Grand hotel Permon****
The conference takes place in the beautiful surroundings of Grand hotel Permon**** in Podbanské, on the border of the High and Western Tatras. The area is framed by the Kamenistá, Tichá and Kôprová valleys, the majestic Kriváň peak (2,494 m) and the nearby Bystrá peak (2,248 m). The clean Belá river gives Podbanské its exceptional natural character.
Full hotel information is available on the official hotel website .
Podbanské, High Tatras, Slovak Republic
GPS coordinates: 49° 8? 48.686565? N / 19° 54? 28.1399345? E
Picturesque Podbanské
Podbanské lies between the High and Western Tatras. Permon Resort offers one of Slovakia’s most popular hotels and a strong background for the expert programme, relaxation and evening networking.
View moreWellness & relax
Conference participants can enjoy the hotel wellness centre during the event. It ranks among the largest and highest-quality wellness complexes in Slovakia and combines saunas, water and steam baths, quiet zones and relaxation areas.
View moreThe High Tatras at your doorstep
After the expert programme, participants can use their free time for a short walk around Podbanské. The surroundings offer peaceful trails, fresh mountain air and views of the Tatra peaks.
View moreRegistration
Registration is invitation-based
Conference registration is handled through an e-mail invitation. The invitation will include a personal registration link.
This page serves as an informational overview of the conference. If you have not received an invitation and would like to attend, you can request one.
E-mail invitation
Registration information will be sent directly in the e-mail invitation.
Registration link
Registration is completed through the personal link included in the invitation.
Don't have an invitation?
If you have not received an invitation and would like to attend, you can request one.
