🇨🇿 Overview of new developments in the regulation of medical devices and IVDs

The event is held in Czech language only!

For many years, the regulation of medical devices has been characterised by its stability and rigidity. There have been minor changes here and there, but the basic legal framework has remained practically unchanged. However, this has changed dramatically in recent years, and not all institutions, and not all personnel involved in medical device regulation, have effective tools to monitor and implement all the rapid changes. Fundamental changes are taking place both in the field of European and national legislation. The new developments concern both general regulation (placing on the market, distribution, use, servicing) and economic regulation (pricing and reimbursement). Broader cross-cutting issues such as regulation of advertising, EHDS, etc. cannot be left aside.

In 2024, Porta Medica has developed an extensive training program including both online webinars and in-person seminars focused in great detail on specific practical regulatory issues. However, we have seen strong demand in feedback for the creation of an occasional event devoted to a relatively brief overview of the wide range of developments in medical device regulation that will take place in the months leading up to such an event. The added value of such a management summary, aimed primarily at the top and middle management of the organisations concerned, should include some overview of expected developments in the near future.

Who the webinar is for:

• managers of manufacturers

• executives of importers and distributors

• middle management of hospitals

• staff of notified bodies

• staff of the Ministry of Health, the Ministry of Medical Affairs and the State Institute of Health Care

• persons working in the healthcare sector with a focus on medical devices

Lecturers:

• Jakub Král

• Alžběta Frýdlová

Content:

• key regulatory deadlines in 2025

• EMDN nomenclature and its practical application

• Eudamed, ISZP and RZPRO databases

• important new developments in MDCG documents

• reporting of supply failures and amendment of the Medical Devices and IVD Act

• public consultation on future changes to the MDR and IVDR

• second public consultation on electronic instructions for use

• regulation (EU) 2023/1542 on batteries

• regulation (EU) 2025/327 EHDS

• important national legislation in process:

  • changes to advertising regulation

  • Medical Devices Categorisation Act

  • amendment of Act 48/1997 Coll.

  • Electronicisation of Health Care Act

  • the price regulation of the Ministry of Health

  • preparation of the legal framework for the regulation of ZUM

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• 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 hosted by:

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

• ID: 17491681, VAT: CZ17491681

• registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město