🇨🇿 MDCG Update: How to Properly Apply the Latest Guidelines?

The event is held in Czech language only!

The webinar program is designed as an intensive, practical guide to the most important recent changes in regulatory practice. In the first part, we will take an in-depth look at the key MDCG 2025-10 guidance document, which provides important information for designing a post-market surveillance (PMS) system and individual post-market surveillance activities. We will then examine borderline cases of medical device classification according to the revised MDCG 2021-24 guidance and demonstrate how the new regime for breakthrough technologies, or Breakthrough Devices (BtX), operates under MDCG 2025-9.

During the webinar, we will also cover the latest developments in the EUDAMED database, where we will explain the new functionality for uploading SS(C)P (MDCG 2026-4), the introduction of the Master UDI-DI concept for specific types of devices, and the latest updates to EMDN codes, as outlined in the set of documents MDCG 2026-1, 2026-2, and 2026-3. Last but not least, we will also examine issues related to the application of Article 10a of the MDR and the relationship between the AI Act and the MDR and IVDR (MDCG 2025-6).

Who is the webinar for:

• Regulatory affairs professionals at medical device and IVD manufacturers

• Regulatory affairs professionals at medical device and IVD importers and distributors

• Staff at notified bodies

• Staff at the Ministry of Health, the Czech Office for Standards, Metrology and Testing ("ÚNMZ"), and the State Institute for Drug Control ("SÚKL")

• Individuals working in healthcare whose activities also involve medical devices or IVDs

Speakers:

• Ing. Jakub Musil

• Ing. Magdalena Folkmanová

Content:

• PMS system (MDCG 2025-10)

• Borderline classification cases (MDCG 2021-24 Rev. 1, manual update)

• Breakthrough devices (BtX) (MDCG 2025-9)

• Changes to the EUDAMED database: SS(C)P functionality (MDCG 2026-4)

• Changes to the EUDAMED database: Master UDI-DI (MDCG 2025-7 Rev. 1, 2025-8 Rev. 1)

• Update to EMDN codes (MDCG 2026-1, 2026-2, 2026-3, MDCG 2021-12 rev. 2)

• Interplay between the MDR/IVDR and the AI Act (MDCG 2025-6)

• Article 10a of the MDR (updated Q&A, Rev. 2)

• Overview of newly published MDCG documents in the second half of 2026

Further information:

• Participants will have the opportunity to ask questions during the webinar

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT 

• 100 % cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar organized by:

• Porta Medica Legal s.r.o., advokátní kancelář

  IČ: 17491681, DIČ: CZ17491681

  Registered office at Opletalova 1525/39, 110 00, Prague 1 - Nové Město