Consultation procedures and borderline products

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Appointment:

December 8, 2026, 9:00 AM - 10:00 AM

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The event has already started!

Organizers

Dr. Eric Sasko

Speaker

Nina Marx

Moderator

Appointments

December 8, 2026, 9:00 AM - 10:00 AM

Webinar information

Join us for our free webinar on December 08, 2026, where our expert, Dr. Eric Sasko, will explain the requirements for borderline products, as well as the relevant consultation procedures under the MDR. Attendees will learn about typical pitfalls and flawed arguments and what manufacturers should keep in mind during the conformity assessment process.

Contents of the webinar:

➡️ Which products can be classified as borderline, combination, or substance-based

➡️ The significance of MDR classification rules 14 and 21

➡️ Gray areas, red flags, common fallacies, and "real-world cases"/examples

➡️ What requirements apply to combination products under Annex IX 5.2

➡️ What requirements must be considered for substance-based products under Annex IX 5.4

➡️ The complete medicinal product consultation process under Annex IX 5.2 for Type 1(8) products

Date: December 08, 2026

Time: 10:00 – 11:00 (CET)

Language: English