🇨🇿 Latest developments in the comprehensive revision of the MDR and IVDR

The event is held in Czech language only!

The European Commission has launched a process of extensive revision of the MDR and IVDR, with the aim of addressing issues that have arisen during their practical application and adapting the regulatory framework to ensure it remains functional and sustainable in the long term. The proposed changes have a significant impact on the functioning of the market for medical devices and in vitro diagnostics and affect a wide range of economic operators and healthcare providers.

The webinar will provide a clear explanation of the direction of the forthcoming revision and outline its basic concept and context. It will focus on why the individual changes are being proposed and what practical implications they may have for regulated practice. The aim is to provide participants with a clear overview of the forthcoming revision and to help them better understand which issues and challenges it will be advisable to monitor as legislative developments progress.

Who is the webinar for:

• Manufacturers of medical devices and in vitro diagnostic (IVD) devices

• Manufacturers of custom-made devices

• Importers of medical devices and IVDs

• Distributors of medical devices and IVDs

• Healthcare providers

• Producers of procedure packs

• Anyone working in the healthcare sector who wishes to broaden their understanding of the fundamentals of this subject

Speakers:

• JUDr. Jakub Král, Ph.D.

• Mgr. Markéta Hrubá

Content:

• An overview of the reasons and objectives behind the European Commission’s proposed revision of the MDR and IVDR

• Changes to key definitions

• New regulatory concepts and tools, in particular ‘well-established technology devices’ and regulatory sandboxes

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

• Changes relating to clinical data, PMS and PMCF

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

• Distance selling, online services and strengthened supervision

• Changes relating to UDI, EUDAMED and the digitisation of documentation

• Notified Bodies and changes to the conformity assessment process

• Crisis powers and tools to ensure the availability of devices

• Expected practical implications of the revision of the MDR and IVDR, and recommendations on how to prepare for the changes

• Information on further legislative developments regarding the forthcoming 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 given to all participants via Porta Medica Academy platform

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