🇨🇿 Great revision of MDR: where is the regulation of medical devices in the EU heading?

The event is held in Czech language only!

The European Commission has launched a comprehensive review of the MDR regulation with the aim of addressing issues that have arisen in their practical application and adjusting the regulatory framework to ensure its long-term functionality and sustainability. The proposed changes have a significant impact on the functioning of the market with medical devices and in vitro diagnostics and affect a wide range of economic operators and healthcare providers alike.

The webinar will offer a clear explanation of the direction the upcoming revision is taking and explain its basic concept and context. It will focus on why individual changes are being proposed and what practical consequences they may have for regulated practice. The aim is to provide participants with a clear overview of the upcoming revision and help them better understand which issues and challenges will be worth monitoring during the course of further legislative developments.

Who is the webinar for:

• Manufacturers of medical devices

• Manufacturers of custom-made devices

• Importers of medical devices

• Distributors of medical devices

• Healthcare providers

• Producers of procedure packs

• Anyone working in healthcare who wants to broaden their horizons by learning the basics of this issue

Speakers:

• JUDr. Jakub Král, Ph.D.

• Mgr. Aneta Dostálová

Content:

• Overview of the reasons and objectives of the proposed revision of the MDR by the European Commission

• Changes in key definitions

• New terms and regulatory tools, in particular well-established technology devices and regulatory sandboxes

• Adjustments to the obligations of manufacturers, distributors, importers, and PRRCs

• Changes in the area of clinical data, PMS, and PMCF

• In-house devices and their new, more proportionate regulatory regime

• Distance sales, online services, and strengthened supervision

• Changes in the area of UDI, EUDAMED, and digitization of documentation

• Notified bodies and changes in the conformity assessment process

• Emergency authority and tools to ensure availability of devices

• Expected practical impacts of the MDR revision and recommendations on how to prepare for the changes

• Information on further legislative developments in the upcoming revision

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