We have renamed our “MDSS Campus” page to "MDSS Forum+" to represent a space where insights are not only discussed but also grounded in experience and application.

MDSS understands how to apply the regulations correctly and pragmatically, rather than simply taking the most conservative approach. Regulatory requirements should be interpreted based on the actual wording and intent of the MDR/IVDR, not on assumptions, historical practices, or overly cautious interpretations. It must be the least burdensome approach.

MDSS is not the company that helps manufacturers “avoid” requirements, we are the company that helps manufacturers apply the requirements correctly, efficiently, and proportionately.

With the least burdensome approach our feeling is that Manufacturers should not be asking how to be more conservative, but how to be compliant in the most efficient and proportionate way. That is where a sound regulatory strategy becomes valuable. And MDSS is here to support you on your compliance journey.

Understanding key EUDAMED terms and correcting common registration mistakes through clear, real-world examples—helping you avoid pitfalls, streamline submissions, and ensure compliance with confidence.

This session addresses common myths regarding the Importer role under the MDR/IVDR, clarifying the regulatory requirements applicable to Importers and the Manufacturer’s actual obligations in relation to them.

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.

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.

Need to sell medical devices in Europe? MDSS makes it easy. Based in Germany with 30+ years of experience, we help with MDR & IVDR registration, Authorized Representative service, EU compliance, post-market surveillance, and more. Fast, reliable, and trusted by companies worldwide. Ready to take the next step?