The MDSS Campus was developed as an educational initiative aimed at increasing awareness and understanding of regulatory requirements for medical devices, in vitro diagnostics, and cosmetics.

Its purpose is to provide clear, accessible, and practical information to manufacturers, distributors, and stakeholders, helping them navigate complex global regulations in regions including the European Union, the United Kingdom, Switzerland, the United States, Australia, and New Zealand.

Through this initiative, MDSS seeks to empower organizations with the knowledge needed to ensure compliance, enhance product safety, and successfully bring products to market.

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, Section 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.

Check these videos for clarification, and contact us for any additional support.

Structured Dialogue, supports early and transparent exchanges between manufacturers and notified bodies to set expectations and reduce incomplete applications.

It is used to clarify expectations and requirements and to help avoid incomplete submissions, while strictly maintaining notified body independence. Structured Dialogue does not constitute consultancy and does not influence conformity assessment outcomes.

Australia’s new UDID system is here…but what does it mean for your medical devices? This video gives you the essentials you need to know and how MDSS can help you stay compliant and competitive. Don’t miss the insights. Watch now to stay ahead.

This educational video explains the roles and responsibilities of the Sponsor and Legal Representative under Article 62. It also highlights how these roles differ from that of an authorized representative, clarifying their distinct functions, legal obligations, and importance within the regulatory framework.

The MDR (Medical Device Regulation) refers to Regulation (EU) 2017/745, the European Union’s legal framework governing the placing on the market, clinical evaluation, post‑market surveillance, and vigilance of medical devices. Watch the video to learn what this regulation means in practice and who is affected.