Upcoming Seminars
Join our Seminars and stay compliant!
We will stimulate the dialog and discussion to identify the best scenario for you and your products.
Substantial changes Annex IX 2.4 — a logical approach
When does a change become “substantial” under the MDR/IVDR—and when must your Notified Body be informed? MDSS is seeing a rising number of questions on this topic under Annex IX 2.4.
Despite the regulation’s clear wording, uncertainty remains widespread across the industry, with differing interpretations and expectations between manufacturers and Notified Bodies continuing to pose a key challenge.
Duration: 45 min plus Q&A
Date: May 20, 2026
Time: 5:00PM CEST / 8:00AM PDT / 11:00AM EDT
Date: May 21, 2026
Time: 9:00AM CEST
The role of the Importer under the MDR/IVDR — Myths, Misconceptions, and Real Obligations
It also examines why, certain stakeholders attribute importer‑related responsibilities to Manufacturers that go beyond what is explicitly required under the Regulations, contributing to ongoing role and accountability confusion within the medical device supply chain.
Send us your questions and share your experiences beforehand so we can have a great discussion together.
Duration: 45 min plus Q&A
Date: June 25, 2026
Time: 9:00AM CEST
Date: June 30, 2026
Time: 5:00PM CEST / 8:00AM PDT / 11:00AM EDT
