🇨🇿 Import and Distribution 2.0: Selected Topics and Updates for 2026

The event is held in Czech language only!

Regulations governing medical devices and IVDs are constantly evolving, raising new practical questions for importers and distributors. This webinar is not intended as a summary of the basic obligations under the MDR and IVDR, but rather as a regulatory update for entities that have already established their core processes and need to keep them up to date. We will focus on selected practical topics, such as the launch of the EUDAMED database, supply chain information obligations in the event of supply disruptions or discontinuations, transition periods for legacy devices, issues related to translations and relabeling, handling complaints and vigilance, and new developments to keep in mind in the coming months and years, such as upcoming changes in advertising, packaging management, and liability for defective products.

Participants will gain an overview of what information to request from manufacturers, what data to verify in available systems, how to set up internal processes for portfolio review and communication with suppliers and customers, and how to prepare for regulatory changes.

Who the webinar is for:

Employees of importers and distributors of medical devices and IVDs, particularly those in the following roles:

• Regulatory specialist

• Quality manager

• Product manager

• Marketing specialist

• Logistics manager

Lecturers:

• Mgr. Aneta Dostálová

• Mgr. Martin Kárász

Content:

• EUDAMED in practice: what will become mandatory, what to verify in the database, and what to continue requesting from the manufacturer

• Supply disruptions and discontinuations: Article 10a of the MDR/IVDR and the sharing of information within the supply chain

• Legacy devices and IVDR deadlines: status of legacy devices, transition periods, and key milestones for IVDs

• Translations, repackaging, and relabeling: limits of Article 16 of the MDR/IVDR, translations of instructions for use and labels

• Complaints and vigilance: what to escalate to manufacturers, how to handle feedback, and what records to keep

• Electronic instructions for use: practical updates for importers and distributors

• Related regulations: MDR/IVDR revisions, packaging management reform under the PPWR, liability for defective products, and upcoming changes in advertising

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